Acupuncture for Prostatectomy Incontinence: Study Protocol for A Multicenter Single Blind Randomized Parallel Controlled Trial

Acupuncture for Prostatectomy Incontinence: Study Protocol for A Multicenter Single Blind Randomized Parallel Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Acupuncture for Prostatectomy Incontinence: Study Protocol for A Multicenter Single Blind Randomized Parallel Controlled Trial Yao Zhang, Shanqi Guo, Chaoran Wang, Xiaodi Liu, Yan Liu, Hongcai Shang, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-530412/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 04 Jan, 2022 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background: Urinary incontinence is a common complication after prostatectomy. Acupuncture is considered an effective treatment for prostatectomy incontinence (PPI), but evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial. Methods: Twenty hospitals will recruit 340 participants with urinary incontinence after prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow up. Eighteen 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h Pad Test;72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed. Discussion: This trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect. Trial Registration: The trial was registered on www.Chictr.org.cn . ChiCTR2100042500. Retrospectively registered on 22 January 2021. Internal Medicine Clinical Pharmacology Acupuncture Prostatectomy incontinence Efficacy Randomized control trial Study protocol Figures Figure 1 Background Prostate cancer is one of the most common malignant tumors of the male genitourinary system and radical prostatectomy is the first-line treatment for localized prostate cancer [ 1 ]. Prostatectomy incontinence (PPI) is a known complication with an incidence rate ranging from 4–31% [ 2 ], which has a significant impact on men’s quality of life (QoL) [ 3 – 4 ]. The complication may generate feelings of low self-esteem, anxiety, and depression. The patients’ shame and discomfort arises from the inability to control the bladder. Patients who do not wish to wear a diaper daily, but always carry it for safety in their bag when leaving home [ 5 ]. The present study revealed that the postoperative period of 2 to 6 months had a severe impact on their QoL [ 6 ]. The treatments for PPI are mainly divided into two types. Conservative treatment includes bladder or pelvic floor muscle training [ 7 – 8 ], biofeedback [ 9 – 10 ], and drug therapy [ 11 – 12 ]. Surgical intervention mainly includes artificial urethral sphincter implantation [ 13 ], urethral suspension [ 14 – 15 ], or injection therapy [ 16 ]. All these treatments may benefit patients; although, it cannot be denied that anti muscarinic drugs such as duloxetine are often accompanied by symptoms of insomnia, nausea, loss of appetite, irritability, and other side effects [ 17 , 18 ]. Further, surgical interventions are traumatic forms of treatment, and are also costly [ 19 ]. Pelvic floor muscle training is the most used conservative treatment for urinary incontinence, but for elderly male patients with prostate cancer, whether functional training is carried out correctly is difficult to evaluate and assess, and it is challenging to implement. Acupuncture, as a typical treatment modality of traditional Chinese medicine (TCM) [ 20 , 21 ]. With few adverse effects, TCM may be used as an alternative treatment approach for patients. Many research centers, mostly in China, have conducted clinical trials to evaluate the safety and effectiveness of acupuncture in managing post-PPI. Liu et al. [ 22 ] conducted a multicenter, randomized clinical trial and revealed that women with stress urinary incontinence can benefit from electroacupuncture involving the lumbosacral region. Chen et al. [ 23 ] determined that acupuncture could be beneficial for men with post-PPI when applied alone or as an adjunct to other conservative therapies and medicines. Therefore, acupuncture could be considered an effective treatment for urinary incontinence. Based on a systematic review [ 23 ], acupuncture may be an appropriate treatment for PPI; However, the quality of evidence has been low and inconclusive. Therefore, we plan to perform a multicenter randomized controlled trial (RCT) to investigate the efficacy and safety of acupuncture in the treatment of PPI in patients with prostate cancer. Methods Study design This study is a multicenter, single blind, randomized parallel controlled prospective clinical trial with the objective of estimating the efficacy and safety of acupuncture on PPI by comparing a verum acupuncture group with a sham acupuncture group. Participants considered suitable for the study will be randomly allocated into the intervention group (verum acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. Study participants Population A target sample of 340 participants will be recruited from 20 hospitals across China: Tianjin Medical University General Hospital; The Second Hospital of Tianjin Medical University; Tianjin Medical University Cancer Hospital; Tianjin First Central Hospital; Tianjin Third Central Hospital; Peking University Third Hospital; Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine; West China Hospital of Sichuan University; Benxi Central Hospital; First Affiliated Hospital of Dalian Medical University; The Second Hospital of Dalian Medical University; The First Affiliated Hospital of Kunming Medical University; Qinghai University Affiliated Hospital; Jiangsu Province People’s Hospital; First Hospital of Shanxi Medical University; Shandong Province Hospital; The Fifth People’s Hospital of Jinan; Inner Mongolia People’s Hospital; The Second Hospital of Anhui Medical University; and Guizhou Province People’s Hospital. Informed consent will be obtained from all participants before randomization. Baseline assessment A baseline registration will be performed before treatment. Participants will provide a review of basic information, malignancy history including operation history, pathology, and QoL assessment including urinary incontinence. A safety evaluation will also be performed. Recruitment We will recruit participants who are attending the 20 above-mentioned hospitals in this trial. We will use WeChat to publish recruitment information, and use the "recruiters" applet to recruit and retrieve information for patients. Inclusion criteria Patients who meet all the following requirements will be allowed to enroll: 1. Patients who have received radical prostatectomy with definite pathological diagnosis of prostate cancer: 2. Diagnosis of urinary incontinence by the International Continuity Society criteria or patients who were evaluated by the urologist as experiencing urinary incontinence resulting from prostate surgery [24]; 3. Karnofsky Score≥60 or Eastern Cooperative Oncology Group (ECOG) Score 0-2; 4. Willing to participate in the study and sign the consent forms. Exclusion criteria Patients who meet all the following criteria will be excluded: 1. Urgency urinary incontinence caused by detrusor hyperreflexia and bladder spasm, and urinary incontinence caused by central system or endocrine factors; 2. Urinary incontinence treated by cystostomy, urethral sphincter reconstruction, or urethral suspension; 3. Currently receiving less than 6 months treatment similar to acupuncture (such as electroacupuncture, warm moxibustion, warm acupuncture, etc.); 4. Irreversible urinary incontinence due to permanent nerve injury and complete loss of function of the external urethral sphincter; 5. Urinary tract infection (except asymptomatic lower urinary tract infection); 6. History of severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, heart failure, or other serious heart diseases; 7. History of severe liver injury or potentially severe liver disease (ALT or AST > 10 times normal); 8. History of severe renal impairment (estimated GFR < 25 mL/min/1.73 m 2 ); 9. History of other important organ dysfunction or hematopoietic system disease, or other serious primary diseases(s); 10. Known to coagulation dysfunction (with typical clinical diagnosis or clear laboratory test results); 11. Patients with mental illness or cognitive impairment, or severe depression; 12. Patients who are not suitable to participate in this study or who are likely to withdraw from the study based on the judgment of the researchers; 13. Patients participating in other clinical trials. Withdrawal from the study Participants will be allowed or asked to withdraw from the study in the following circumstances: 1. Patients who express an unwillingness to being subjected to the assigned treatment for various reasons at any stage of the trial; 2. Patients experience an adverse events (AE) that necessitates their withdrawal from the trial; 3. Patients who cannot fully participate in the treatment or follow-up period; 4. Patients can withdraw from the study voluntarily for any reason. Randomization and blinding A total of 340 participants will be randomly allocated into the treatment group or the control group. Each hospital will recruit 17 patients. In this trial, we will carry out block randomization in a 1:1 ratio according to the sequence generated using SAS software version 9.4 (SAS Institute Inc. Cary, NC). Random allocation will be performed after eligible participants consent in written form and complete baseline assessments. The participants, outcome assessors, and statisticians will be blinded to treatment allocation. The acupuncturist will not be blinded to the participant’s allocation. All participants in the study will sign a confidentiality commitment to avoid blind disclosure. Ethics The study will be performed in accordance with the principles of the Declaration of Helsinki, and has been approved by the ethics committee boards of the participating hospitals. Written informed consent will be obtained from each subject before the patients are enrolled in the trial. Ethical approval is provided as Additional file 1. Interventions According to the predetermined randomization results, participants will be randomly allocated to the verum or sham acupuncture group. All participants will go through a standardized interview, which will be recorded on the case report forms. To minimize bias, all the acupuncturists in this trial are specialists in acupuncture. They have a minimum of 2 years’ experience in acupuncture treatment and hold licenses to perform acupuncture. Before performing this trial, all acupuncturists will receive special training regarding the purpose and content of the trial, treatment strategies, and quality control. The flowchart and study design schedule are presented in Figure 1 and Table 1, respectively. The trial will last 24 weeks, including treatment and follow-up periods. All participants will receive treatment for 6 weeks. Participants in both groups will receive verum or sham acupuncture three times a week (recommended interval of one day). Each acupuncture session requires approximately 20 minutes to perform. Sterile needles for single use (0.25×40 mm; Jiangsu Medical Supplies Factory Co., Ltd.) will be used in this study. Needles in the treatment group will be inserted at a depth of 0.8-1 inches and manually manipulated by rotation methods. After acupuncture, the patient's "De Qi" should be taken as the criterion (the feeling of pain and numbness). In the control group, needles will be inserted about 0.5 inch in depth, and will not receive further manipulation. To prevent blind uncovering, the operator will pay attention to the depth and angle of the shallow stab. All participants will be evaluated by blind method at week 6 after acupuncture. The Blind Method Assessment is shown in Additional file 2. Table 1 Study design schedule Contents Research period Screening Baseline Treatment (W1-6) Follow-up (W7-24) W-1 W0 W1 W2 W4 W6 W12 W18 W24 Visit V0 V1 V2 V3 V4 V5 V6 V7 V8 Name × × Age × × Contact information × Inclusion/Exclusion criteria × Informed consent × Screening dispose × Randomization × Vital signs 1 × × × × × × Blood routine 2 × × × Urine routine 3 × × × Biochemical items 4 × × × ECG 5 × × × Height × Weight × BMI 6 × Education and occupation × Karnofsky score × ECOG score 7 × Personal history 8 × Past History × physical examination 9 × × × × × Diagnosis time × Pathological type × Gleason score × Clinical stages × Operation type × Treatment of PPI × × × × × × × × Treatment of PCa × × × × × × × × Daily water consumption × × × × × × × × Drink preference × × × × × × × × Postoperative extubation time × Time of incontinence × ICIQ-UI SF 10 × × × × × 1-hour pad test × × × 72-h voiding diary × × × × × × × × EPIC-26 11 × × × × × SAS 12 × × × × × Weekly consumption of pads × × × × × × × × Severity of PPI × × × × × Self-assessment × × × × Blind assessment × Major AE of PCa 13 × × × × × × × AE 14 × × × × × × × SAE 15 × × × × × × × Notes: Vital signs: blood pressure, pulse, body temperature and respiration; Blood routine: hemoglobin, red blood cell count, white blood cell count, lymphocyte, neutrophil, and platelet count; Urine routine: white blood cell, red blood cell, protein, and ketone body; Biochemical items: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea nitrogen, glomerular filtration rate, creatinine, glucose, triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, potassium, sodium, calcium; ECG: electrocardiogram; BMI: body mass index; ECOG score: Eastern Cooperative Oncology Group score; Personal history: including family history, smoking history, drinking history, drug and food allergy history, marriage history, occupational exposure history; Physical examination: the researchers will conduct a comprehensive physical examination at baseline, including general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lung, heart, abdomen, back, lymph nodes, limbs, and nervous system examination. All other visits will have a brief physical examination, i.e., a general appearance examination; ICIQ-UI SF: International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form; EPIC-26: The Expanded Prostate Cancer Index Composite 26-item version; SAS: Self-Rating Anxiety Scale is a 20-item self-report assessment; Major adverse event (AE) of prostate cancer (PCa): It refers to the AEs related to the progression of PCa from the time of enrollment to the end of follow-up; AE: It refers to the AEs caused by the intervention measures of the project from the time of admission to the end of follow-up; SAE: It refers to the serious adverse events caused by the intervention measures of the project during the period from enrollment to the end of follow-up. Acupoints used in the treatment group The stimulation points in the intervention group will be RN12 (Zhongwan), RN6 (Qihai), ST36 (Zusanli, bilaterally), SP6 (Sanyinjiao, bilaterally), SP9 (Yinlingquan, bilaterally), SP10 (Shuidao), RN3 (Zhongji), and RN2 (Qugu). All acupoints are located according to the National Standard of People's Republic of China (GB / T 12346-2006). The acupoint diagram is shown in Additional file 3. Sham acupoints used in the control group To ensure the quantity of stimulus is uniform between two groups, the same kind, size, and number of needles will be used for the control group. However, the control group will be treated with shallow needling at the non-meridian and non-acupoint positions. The acupuncture points shifted 1-inch from the actual location and have no therapeutic value. Permitted and prohibited concomitant treatments Both groups can receive conventional treatment for prostate cancer (such as endocrine therapy) and/or pelvic floor muscle training, which differ from acupuncture principles. Researchers need to keep a detailed record. Treatments like the principles of acupuncture are not allowed. Outcome measures Primary outcome measures ICIQ-UI-SF The International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form. Scores of the scale will be calculated to investigate the incidence of urinary incontinence and the impact of urinary incontinence on patients. It will be used at baseline, and at weeks 6, 12, 18, and 24. The scale is shown in Additional file 4. Secondary outcome measures 1-h Pad Test It is a test to objectively evaluate urinary incontinence. It is measured to assess the change in volume of urine leakage from baseline at weeks 4 and 6. 72-hour Voiding Diary On the basis of not changing life status and urination habits, 72 hours of fluid intake and urination time are continuously recorded every week. It is used to assess the change in mean 72-hour incontinence-episode frequency (IEF) from baseline, and at weeks 1, 2, 4, 6, 12, 18, and 24. The scale is shown in Additional file 5. EPIC-26 The Expanded Prostate Cancer Index Composite 26-item version includes three categories of questions aimed to evaluate the prostate function and QoL of patients with prostate cancer in the past 4 weeks. Evaluated at weeks 6, 12, 18, and 24, changes in scores from the baseline will be analyzed. The scale is shown in Additional file 6. SAS Self-Rating Anxiety Scale is a 20-item self-report assessment used to measure anxiety levels, based on the scoring of 4 groups of symptoms: cognitive, autonomic, motor, and central nervous system symptoms. The scores will be evaluated at weeks 6, 12, 18, and 24, and changes in scores from the baseline values will be analyzed. The scale is shown in Additional file 7. Weekly consumption of pads Changing and average weekly consumption of pads at weeks 1, 2, 4, 6, 12, 18, and 24 from the baseline will be calculated. Severity of urinary incontinence It will be evaluated at weeks 6, 12, 18 and 24. The change in the number and percentage of severity ratings from the baseline value will be analyzed. Self-report assessment of therapeutic effect A 4-point scale is used: no help, little help, medium help, and great help [25]. Treatment effects will be evaluated at weeks 6, 12, 18, and 24. Safety assessment To exclude any related serious diseases, patients will be asked to undergo necessary inspection before randomization, including vital signs, blood routine, urine routine, biochemical items, ECG. These tests will be performed at the week 6 of the study to evaluate the safety of this trial. If any AEs occur during the trial, patients will be treated as soon as possible. Statistical methods Sample size calculation By enrolling approximately 340 (170 in each group) participants, the study will provide 90% power to detect a between-group difference of 2.5 in reduction of ICI-Q-SF score from baseline using a 2-sided alpha level of 0.05, and assuming a common standard deviation of 6.3 and a dropout rate of 20%. A difference of 2.5 points in the ICI-Q-SF score was selected for sample size calculations, which is indicative of a clinically significant change [25–27]. Statistical analysis Summary tables (descriptive statistics and/or frequency tables) will be provided for all variables as appropriate. The primary outcome analysis will use the Cochran-Mantel-Haenszel (CMH) test. For continuous variables, means and standard deviations will be presented, unless the variable has a skewed distribution, in which medians, 25th and 75th percentiles will be presented. For other categorical data, between group comparisons will be performed using a Wilcoxon rank-sum test, chi-square test, or Fisher’s exact test, as appropriate. AE incidences for each treatment group will be tested by the c2 test or Fisher’s exact test as appropriate. All the statistical analysis will be performed using SAS version 9.4 (SAS Institute Inc) with 2-sided tests at a significance level of <0.05. Discussion PPI has a significant impact on the QoL of patients who undergo prostatectomy. It is closely associated with the trauma caused by surgery [ 28 , 29 ]. Although urinary incontinence after prostate cancer heals within half a year, the need for active improvement of symptoms and the QoL of patients is widely recognized [ 30 ]. Surgical resection of prostate cancer mainly includes bladder neck, bilateral vas deferens ampulla, bilateral seminal vesicles, and the intact prostate. Although a complete resection of the tumor and avoidance of positive surgical edge can be achieved, often the bladder neck and part of the prostatic apex urethra are removed, which will lead to damage of the urinary control structure. In addition, due to intraoperative bleeding, tumor infiltration, and adhesion, the distal sphincter, fascia, ligament, and pelvic floor muscles may be damaged, which leads to postoperative urinary incontinence [ 31 , 32 ]. The efficacy of acupuncture has been proved by many RCTs [ 33 ]. A systematic review demonstrated that acupuncture was an appropriate adjunctive therapy for PPI, but the supporting evidence was not sufficient. These limitations included small sample size, greater-than-anticipated withdrawal, the lack of a control group, and unclear statements about randomized allocation. Therefore, more powerful evidence is still needed to verify the efficacy and safety of acupuncture for PPI. We have presented the design of a RCT of verum acupuncture compared with sham acupuncture. Completion of this trial will contribute to verifying the efficacy of acupuncture for the treatment of PPI. This multicenter study covers 13 provinces and cities from south to north in China, we hope that the results will provide robust evidence to support the application of acupuncture in the treatment of postoperative incontinence of prostate cancer. Declarations Ethics approval and consent to participate: The trial has passed the ethical application, and the participants signed an informed consent form. Competing interests: The authors declare that they have no competing interests. And agree to public the protocol and follow-up research data. Funding: National Administration of Traditional Chinese Medicine : 2019 Project of building evidence based practice capacity for TCM(2019XZZX-ZL007). Authors' contributions: Yingjie Jia and Xiaojiang Li drew up the research design. Yao Zhang drafted the protocol and wrote the manuscript in English. Shanqi Guo, Liang Wang and Peiying Yang participated in the design amendment. Yao Zhang, Shanqi Guo, Chaoran Wang and Xiaodi Liu contributed to protocol ethics and trial registration. Yan Liu and Jingbo Zhai revised the details and the language.Yan Liu made the statistical plan. All authors reviewed the manuscript content and approved the final version for submission. Acknowledgements: Thanks to the China Academy of Chinese Medical Sciences of China Center for Evidence Based Traditional Chinese Medicine and Guang'anmen Hospital of China Academy of Chinese Medical Sciences for guiding the project. Thanks to the Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine for Revising research plan. References Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021;71:7-33. Litwin MS, Tan HJ. 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Tianjin Traditional Chinese Medicine, 2015,32 (09): 542-545. Supplementary Files SPIRITchecklist.docx renamedacbb7.pdf Additional file 1:Ethical Approval Document BlindMethodAssessment.docx Additional file 2:The Blind Method Assessment picture.docx Additional file 3. The acupoint diagram renamed381de.pdf Additional file 4. The ICIQ-UI-SF Scale renamed15112.pdf Additional file 5. 72-hour Voiding Diary renamed216ee.pdf Additional file 6. The EPIC-26 scale renamedf16a7.pdf Additional file 7. The Self-Rating Anxiety scale Cite Share Download PDF Status: Published Journal Publication published 04 Jan, 2022 Read the published version in Trials → Version 1 posted Editorial decision: Major revision 19 Jul, 2021 Reviews received at journal 15 Jun, 2021 Reviewers invited by journal 14 Jun, 2021 Editor assigned by journal 11 Jun, 2021 First submitted to journal 15 May, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-530412","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":33512278,"identity":"28d52f52-76cf-4be4-95d0-eba4f5320cd5","order_by":0,"name":"Yao Zhang","email":"","orcid":"","institution":"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yao","middleName":"","lastName":"Zhang","suffix":""},{"id":33512279,"identity":"03c7e1b5-604b-4575-800b-9d162ced35d8","order_by":1,"name":"Shanqi 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Liu","email":"","orcid":"","institution":"Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yan","middleName":"","lastName":"Liu","suffix":""},{"id":33512283,"identity":"c53503a6-b828-4774-886e-808b9a692110","order_by":5,"name":"Hongcai Shang","email":"","orcid":"","institution":"Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hongcai","middleName":"","lastName":"Shang","suffix":""},{"id":33512284,"identity":"852024c5-6f51-4a2a-bba0-7c56c2c7e02d","order_by":6,"name":"Peiying Yang","email":"","orcid":"","institution":"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Peiying","middleName":"","lastName":"Yang","suffix":""},{"id":33512285,"identity":"6248977c-c073-4afa-835f-a9383fe2ffce","order_by":7,"name":"Liang Wang","email":"","orcid":"","institution":"Tianjin Medical University General Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Liang","middleName":"","lastName":"Wang","suffix":""},{"id":33512286,"identity":"c689ce3e-2910-4419-ba4e-51e2ff5eba36","order_by":8,"name":"Jingbo Zhai","email":"","orcid":"","institution":"Tianjin University of Traditional Chinese Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jingbo","middleName":"","lastName":"Zhai","suffix":""},{"id":33512287,"identity":"1552ea5f-b645-4486-845d-d2e565ff71b3","order_by":9,"name":"Xiaojiang Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1klEQVRIie2QMQrCQBBFJwS0GUknEcVcYYOteJaEgLVlyhSSKgdI8BKxs5xlIdXaCzYBLxCxFXQNFlbJ2gnuK6b6j88fAIPhN7FInRmAIGpiTeelIEAV8lx+p+BCjLYacS+PSrqmS2RcNjRKwHPG1K1YWbXhRbrGSXIsaXIAv9gF3Yo9zJhAKdABpfgSAnbuUQY2vpQHDkDWFKYaCrYtMakWCcR1FBfVljyO1JaK8US6/VvUx/Z1w1ZzdhKX2z1ees60R1Gwdx+1tzf+oTiJVtpgMBj+kCeh7Uq9V6DYiAAAAABJRU5ErkJggg==","orcid":"","institution":"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Xiaojiang","middleName":"","lastName":"Li","suffix":""},{"id":33512288,"identity":"679cef88-917b-4f0d-8388-8a1f171994ed","order_by":10,"name":"Yingjie Jia","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA/ElEQVRIiWNgGAWjYBACxmYgkcDAwMzGwNj4IKHChoGNBC3MzQYPzqQR1oIE2NsEH7YcJqyOuZ35mcTDHbXsfOyNbQyJDeft+aSbHzD8qNiGx2FsZhKJZ44zs/EcbHuQuON2YpvMMQPGnjO38fkFqKXtGDObRGK7QeKZ2wlsEgkGzIxt+LSwf4NokX/YBmScs2eTSP9AQAsPyJYaoC2MIC0HgGQOIVt4ii2AKoF+SWw2SDiTnAjUUnAQn18M+49vvPmzrS5Zvv34w4c/Kuzs5Wekb3zwowKPlgYGFgkGhsPJKKIHcKoHAnlg1HxgYKizw6doFIyCUTAKRjgAAH/1VyAeBp0gAAAAAElFTkSuQmCC","orcid":"","institution":"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Yingjie","middleName":"","lastName":"Jia","suffix":""}],"badges":[],"createdAt":"2021-05-16 13:57:41","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-530412/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-530412/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-021-05805-5","type":"published","date":"2022-01-04T07:53:24+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":10615746,"identity":"74fc3cd6-b432-4f2d-88f8-b75e452b9dba","added_by":"auto","created_at":"2021-06-21 20:22:44","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":50549,"visible":true,"origin":"","legend":"Trial flowchart. UI urinary incontinence; PC prostate cancer; PPI prostatectomy incontinence.","description":"","filename":"fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/3e48e629fd4f23b8161bfca4.png"},{"id":16967256,"identity":"3b6ff5dd-dca4-4a43-9408-a63324c3f45c","added_by":"auto","created_at":"2022-01-04 07:53:27","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":620266,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/2187d23e-dc1e-445b-9f1c-9a1634a9b4b6.pdf"},{"id":10615805,"identity":"826279d2-c6a3-4592-974e-c70b149be8b1","added_by":"auto","created_at":"2021-06-21 20:25:44","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":30060,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/fff08868a9e32d18f9931744.docx"},{"id":10615747,"identity":"1737e44a-0f96-4e82-b093-51412b323284","added_by":"auto","created_at":"2021-06-21 20:22:44","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":727704,"visible":true,"origin":"","legend":"Additional file 1:Ethical Approval Document","description":"","filename":"renamedacbb7.pdf","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/3ec651689824cab8e002e8cd.pdf"},{"id":10615666,"identity":"5b6c4bc9-09eb-4938-9c9f-6fb215e37403","added_by":"auto","created_at":"2021-06-21 20:19:44","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":31350,"visible":true,"origin":"","legend":"Additional file 2:The Blind Method Assessment","description":"","filename":"BlindMethodAssessment.docx","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/3a7d953add4ab997579e6116.docx"},{"id":10615831,"identity":"096a6a04-7696-4983-92b3-061e4b76ab53","added_by":"auto","created_at":"2021-06-21 20:28:44","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":175192,"visible":true,"origin":"","legend":"Additional file 3. The acupoint diagram","description":"","filename":"picture.docx","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/90fc678e8154d12703ad84ee.docx"},{"id":10615807,"identity":"00f2079a-81f0-4af3-8870-46d610557e75","added_by":"auto","created_at":"2021-06-21 20:25:44","extension":"pdf","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":151071,"visible":true,"origin":"","legend":"Additional file 4. The ICIQ-UI-SF Scale","description":"","filename":"renamed381de.pdf","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/3d53826b0f062a4e79e4f7f4.pdf"},{"id":10615672,"identity":"cc3bf472-f486-4bf6-8439-9bd4939f7115","added_by":"auto","created_at":"2021-06-21 20:19:44","extension":"pdf","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":147430,"visible":true,"origin":"","legend":"Additional file 5. 72-hour Voiding Diary","description":"","filename":"renamed15112.pdf","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/b9acc175885d6d91ac2defdd.pdf"},{"id":10615750,"identity":"8561e2bf-b6d3-4074-bf0a-7bf584a1eee8","added_by":"auto","created_at":"2021-06-21 20:22:44","extension":"pdf","order_by":7,"title":"","display":"","copyAsset":false,"role":"supplement","size":121671,"visible":true,"origin":"","legend":"Additional file 6. The EPIC-26 scale","description":"","filename":"renamed216ee.pdf","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/7e872fc93aa385a22893cf42.pdf"},{"id":10615752,"identity":"54dc9af0-62ec-4549-939c-e8506ab4bb5b","added_by":"auto","created_at":"2021-06-21 20:22:44","extension":"pdf","order_by":8,"title":"","display":"","copyAsset":false,"role":"supplement","size":98835,"visible":true,"origin":"","legend":"Additional file 7. The Self-Rating Anxiety scale","description":"","filename":"renamedf16a7.pdf","url":"https://assets-eu.researchsquare.com/files/rs-530412/v1/4ed9c7e3f50ece52cbe08e14.pdf"}],"financialInterests":"","formattedTitle":"\u003cp\u003eAcupuncture for Prostatectomy Incontinence: Study Protocol for A Multicenter Single Blind Randomized Parallel Controlled Trial\u003c/p\u003e","fulltext":[{"header":"Background","content":" \u003cp\u003eProstate cancer is one of the most common malignant tumors of the male genitourinary system and radical prostatectomy is the first-line treatment for localized prostate cancer [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Prostatectomy incontinence (PPI) is a known complication with an incidence rate ranging from 4\u0026ndash;31% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], which has a significant impact on men\u0026rsquo;s quality of life (QoL) [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The complication may generate feelings of low self-esteem, anxiety, and depression. The patients\u0026rsquo; shame and discomfort arises from the inability to control the bladder. Patients who do not wish to wear a diaper daily, but always carry it for safety in their bag when leaving home [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The present study revealed that the postoperative period of 2 to 6 months had a severe impact on their QoL [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe treatments for PPI are mainly divided into two types. Conservative treatment includes bladder or pelvic floor muscle training [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e], biofeedback [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], and drug therapy [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Surgical intervention mainly includes artificial urethral sphincter implantation [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], urethral suspension [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], or injection therapy [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. All these treatments may benefit patients; although, it cannot be denied that anti muscarinic drugs such as duloxetine are often accompanied by symptoms of insomnia, nausea, loss of appetite, irritability, and other side effects [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Further, surgical interventions are traumatic forms of treatment, and are also costly [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Pelvic floor muscle training is the most used conservative treatment for urinary incontinence, but for elderly male patients with prostate cancer, whether functional training is carried out correctly is difficult to evaluate and assess, and it is challenging to implement.\u003c/p\u003e \u003cp\u003eAcupuncture, as a typical treatment modality of traditional Chinese medicine (TCM) [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. With few adverse effects, TCM may be used as an alternative treatment approach for patients. Many research centers, mostly in China, have conducted clinical trials to evaluate the safety and effectiveness of acupuncture in managing post-PPI. Liu et al. [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] conducted a multicenter, randomized clinical trial and revealed that women with stress urinary incontinence can benefit from electroacupuncture involving the lumbosacral region. Chen et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] determined that acupuncture could be beneficial for men with post-PPI when applied alone or as an adjunct to other conservative therapies and medicines. Therefore, acupuncture could be considered an effective treatment for urinary incontinence.\u003c/p\u003e \u003cp\u003eBased on a systematic review [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], acupuncture may be an appropriate treatment for PPI; However, the quality of evidence has been low and inconclusive. Therefore, we plan to perform a multicenter randomized controlled trial (RCT) to investigate the efficacy and safety of acupuncture in the treatment of PPI in patients with prostate cancer.\u003c/p\u003e "},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is a multicenter, single blind, randomized parallel controlled prospective clinical trial with the objective of estimating the efficacy and safety of acupuncture on PPI by comparing a verum acupuncture group with a sham acupuncture group. Participants considered suitable for the study will be randomly allocated into the intervention group (verum acupuncture) or the control group (sham acupuncture) in a 1:1 ratio.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePopulation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA target sample of 340 participants will be recruited from 20 hospitals across China: Tianjin Medical University General Hospital; The Second Hospital of Tianjin Medical University; Tianjin Medical University Cancer Hospital; Tianjin First Central Hospital; Tianjin Third Central Hospital; Peking University Third Hospital; Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine; West China Hospital of Sichuan University; Benxi Central Hospital; First Affiliated Hospital of Dalian Medical University; The Second Hospital of Dalian Medical University; The First Affiliated Hospital of Kunming Medical University; Qinghai University Affiliated Hospital; Jiangsu Province People\u0026rsquo;s Hospital; First Hospital of Shanxi Medical University; Shandong Province Hospital; The Fifth People\u0026rsquo;s Hospital of Jinan; Inner Mongolia People\u0026rsquo;s Hospital; The Second Hospital of Anhui Medical University; and Guizhou Province People\u0026rsquo;s Hospital. Informed consent will be obtained from all participants before randomization.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eBaseline assessment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA baseline registration will be performed before treatment. Participants will provide a review of basic information, malignancy history including operation history, pathology, and QoL assessment including urinary incontinence. A safety evaluation will also be performed.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eRecruitment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will recruit participants who are attending the 20 above-mentioned hospitals in this trial. We will use WeChat to publish recruitment information, and use the \u0026quot;recruiters\u0026quot; applet to recruit and retrieve information for patients.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients who meet all the following requirements will be allowed to enroll:\u003c/p\u003e\n\u003cp\u003e1. Patients who have received radical prostatectomy with definite pathological diagnosis of prostate cancer:\u003c/p\u003e\n\u003cp\u003e2. Diagnosis of urinary incontinence by the International Continuity Society criteria or patients who were evaluated by the urologist as experiencing urinary incontinence resulting from prostate surgery [24];\u003c/p\u003e\n\u003cp\u003e3. Karnofsky Score\u0026ge;60 or Eastern Cooperative Oncology Group (ECOG) Score 0-2;\u003c/p\u003e\n\u003cp\u003e4. Willing to participate in the study and sign the consent forms.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients who meet all the following criteria will be excluded:\u003c/p\u003e\n\u003cp\u003e1. Urgency urinary incontinence caused by detrusor hyperreflexia and bladder spasm, and urinary incontinence caused by central system or endocrine factors;\u003c/p\u003e\n\u003cp\u003e2. Urinary incontinence treated by cystostomy, urethral sphincter reconstruction, or urethral suspension;\u003c/p\u003e\n\u003cp\u003e3. Currently receiving less than 6 months treatment similar to acupuncture (such as electroacupuncture, warm moxibustion, warm acupuncture, etc.);\u003c/p\u003e\n\u003cp\u003e4. Irreversible urinary incontinence due to permanent nerve injury and complete loss of function of the external urethral sphincter;\u003c/p\u003e\n\u003cp\u003e5. Urinary tract infection (except asymptomatic lower urinary tract infection);\u003c/p\u003e\n\u003cp\u003e6. History of severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, heart failure, or other serious heart diseases;\u003c/p\u003e\n\u003cp\u003e7. History of severe liver injury or potentially severe liver disease (ALT or AST \u0026gt; 10 times normal);\u003c/p\u003e\n\u003cp\u003e8. History of severe renal impairment (estimated GFR \u0026lt; 25 mL/min/1.73 m\u003csup\u003e2\u003c/sup\u003e);\u003c/p\u003e\n\u003cp\u003e9. History of other important organ dysfunction or hematopoietic system disease, or other serious primary diseases(s);\u003c/p\u003e\n\u003cp\u003e10. Known to coagulation dysfunction (with typical clinical diagnosis or clear laboratory test results);\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e11. Patients with mental illness or cognitive impairment, or severe depression;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e12. Patients who are not suitable to participate in this study or who are likely to withdraw from the study based on the judgment of the researchers;\u003c/p\u003e\n\u003cp\u003e13. Patients participating in other clinical trials.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eWithdrawal from the study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will be allowed or asked to withdraw from the study in the following circumstances:\u003c/p\u003e\n\u003cp\u003e1. Patients who express an unwillingness to being subjected to the assigned treatment for various reasons at any stage of the trial;\u003c/p\u003e\n\u003cp\u003e2. Patients experience an adverse events (AE) that necessitates their withdrawal from the trial;\u003c/p\u003e\n\u003cp\u003e3. Patients who cannot fully participate in the treatment or follow-up period;\u003c/p\u003e\n\u003cp\u003e4. Patients can withdraw from the study voluntarily for any reason.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eRandomization and blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 340 participants will be randomly allocated into the treatment group or the control group. Each hospital will recruit 17 patients. In this trial, we will carry out block randomization in a 1:1 ratio according to the sequence generated using SAS software version 9.4 (SAS Institute Inc. Cary, NC). Random allocation will be performed after eligible participants consent in written form and complete baseline assessments. The participants, outcome assessors, and statisticians will be blinded to treatment allocation. The acupuncturist will not be blinded to the participant\u0026rsquo;s allocation. All participants in the study will sign a confidentiality commitment to avoid blind disclosure.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eEthics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will be performed in accordance with the principles of the Declaration of Helsinki, and has been approved by the ethics committee boards of the participating hospitals. Written informed consent will be obtained from each subject before the patients are enrolled in the trial. Ethical approval is provided as Additional file 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the predetermined randomization results, participants will be randomly allocated to the verum or sham acupuncture group. All participants will go through a standardized interview, which will be recorded on the case report forms. To minimize bias, all the acupuncturists in this trial are specialists in acupuncture. They have a minimum of 2 years\u0026rsquo; experience in acupuncture treatment and hold licenses to perform acupuncture. Before performing this trial, all acupuncturists will receive special training regarding the purpose and content of the trial, treatment strategies, and quality control. The flowchart and study design schedule are presented in Figure 1 and Table 1, respectively.\u003c/p\u003e\n\u003cp\u003eThe trial will last 24 weeks, including treatment and follow-up periods. All participants will receive treatment for 6 weeks. Participants in both groups will receive verum or sham acupuncture three times a week (recommended interval of one day). Each acupuncture session requires approximately 20 minutes to perform. Sterile needles for single use (0.25\u0026times;40 mm; Jiangsu Medical Supplies Factory Co., Ltd.) will be used in this study. Needles in the treatment group will be inserted at a depth of 0.8-1 inches and manually manipulated by rotation methods. After acupuncture, the patient\u0026apos;s \u0026quot;De Qi\u0026quot; should be taken as the criterion (the feeling of pain and numbness). In the control group, needles will be inserted about 0.5 inch in depth, and will not receive further manipulation. To prevent blind uncovering, the operator will pay attention to the depth and angle of the shallow stab. All participants will be evaluated by blind method at week 6 after acupuncture. The Blind Method Assessment is shown in Additional file 2. \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 1 Study design schedule\u003c/p\u003e\n\u003ctable align=\"right\" border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" width=\"26.80921052631579%\"\u003e\n \u003cp\u003e\u003cstrong\u003eContents\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"9\" width=\"73.1907894736842%\"\u003e\n \u003cp\u003e\u003cstrong\u003eResearch period\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"12.808988764044944%\"\u003e\n \u003cp\u003e\u003cstrong\u003eScreening\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.808988764044944%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBaseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"4\" width=\"42.69662921348315%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment (W1-6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" width=\"31.685393258426966%\"\u003e\n \u003cp\u003e\u003cstrong\u003eFollow-up (W7-24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"12.723214285714286%\"\u003e\n \u003cp\u003eW-1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.723214285714286%\"\u003e\n \u003cp\u003eW0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.714285714285714%\"\u003e\n \u003cp\u003eW1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.714285714285714%\"\u003e\n \u003cp\u003eW2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.714285714285714%\"\u003e\n \u003cp\u003eW4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.714285714285714%\"\u003e\n \u003cp\u003eW6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.714285714285714%\"\u003e\n \u003cp\u003eW12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.714285714285714%\"\u003e\n \u003cp\u003eW18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.267857142857142%\"\u003e\n \u003cp\u003eW24\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eVisit\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003eV0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003eV1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003eV2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003eV3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003eV4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003eV5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003eV6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003eV7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003eV8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eName\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eContact information\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eInclusion/Exclusion criteria\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eInformed consent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eScreening dispose\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eRandomization\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eVital signs \u003csup\u003e1\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBlood routine \u003csup\u003e2\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eUrine routine\u003csup\u003e3\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBiochemical items \u003csup\u003e4\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eECG \u003csup\u003e5\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eHeight\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eWeight\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBMI\u003csup\u003e6\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eEducation and occupation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eKarnofsky score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eECOG score\u003csup\u003e7\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePersonal history\u003csup\u003e8\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePast History\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003ephysical examination\u003csup\u003e9\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiagnosis time\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePathological type\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eGleason score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eClinical stages\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eOperation type\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment of PPI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment of PCa\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDaily water consumption\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDrink preference\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePostoperative extubation time\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTime of incontinence\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eICIQ-UI SF\u003csup\u003e10\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003e1-hour pad test\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003e72-h voiding diary\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eEPIC-26\u003csup\u003e11\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eSAS\u003csup\u003e12\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eWeekly consumption of pads\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eSeverity of PPI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eSelf-assessment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBlind assessment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eMajor AE of PCa\u003csup\u003e13\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAE\u003csup\u003e14\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.67757774140753%\"\u003e\n \u003cp\u003e\u003cstrong\u003eSAE\u003csup\u003e15\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.328968903436989%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.855973813420622%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.528641571194763%\"\u003e\n \u003cp\u003e\u0026times;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eNotes:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eVital signs: blood pressure, pulse, body temperature and respiration;\u003c/li\u003e\n \u003cli\u003eBlood routine: hemoglobin, red blood cell count, white blood cell count, lymphocyte, neutrophil, and platelet count;\u003c/li\u003e\n \u003cli\u003eUrine routine: white blood cell, red blood cell, protein, and ketone body;\u003c/li\u003e\n \u003cli\u003eBiochemical items: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea nitrogen, glomerular filtration rate, creatinine, glucose, triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, potassium, sodium, calcium;\u003c/li\u003e\n \u003cli\u003eECG: electrocardiogram;\u003c/li\u003e\n \u003cli\u003eBMI: body mass index;\u003c/li\u003e\n \u003cli\u003eECOG score: Eastern Cooperative Oncology Group score;\u003c/li\u003e\n \u003cli\u003ePersonal history: including family history, smoking history, drinking history, drug and food allergy history, marriage history, occupational exposure history;\u003c/li\u003e\n \u003cli\u003ePhysical examination: the researchers will conduct a comprehensive physical examination at baseline, including general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lung, heart, abdomen, back, lymph nodes, limbs, and nervous system examination. All other visits will have a brief physical examination, i.e., a general appearance examination;\u003c/li\u003e\n \u003cli\u003eICIQ-UI SF: International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form;\u003c/li\u003e\n \u003cli\u003eEPIC-26: The Expanded Prostate Cancer Index Composite 26-item version;\u003c/li\u003e\n \u003cli\u003eSAS: Self-Rating Anxiety Scale is a 20-item self-report assessment;\u003c/li\u003e\n \u003cli\u003eMajor adverse event (AE) of prostate cancer (PCa): It refers to the AEs related to the progression of PCa from the time of enrollment to the end of follow-up;\u003c/li\u003e\n \u003cli\u003eAE: It refers to the AEs caused by the intervention measures of the project from the time of admission to the end of follow-up;\u003c/li\u003e\n \u003cli\u003eSAE: It refers to the serious adverse events caused by the intervention measures of the project during the period from enrollment to the end of follow-up.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eAcupoints used in the treatment group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe stimulation points in the intervention group will be RN12 (Zhongwan), RN6 (Qihai), ST36 (Zusanli, bilaterally), SP6 (Sanyinjiao, bilaterally), SP9 (Yinlingquan, bilaterally), SP10 (Shuidao), RN3 (Zhongji), and RN2 (Qugu). All acupoints are located according to the National Standard of People\u0026apos;s Republic of China (GB / T 12346-2006). The acupoint diagram is shown in Additional file 3.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSham acupoints used in the control group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo ensure the quantity of stimulus is uniform between two groups, the same kind, size, and number of needles will be used for the control group. However, the control group will be treated with shallow needling at the non-meridian and non-acupoint positions. The acupuncture points shifted 1-inch from the actual location and have no therapeutic value.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003ePermitted and prohibited concomitant treatments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth groups can receive conventional treatment for prostate cancer (such as endocrine therapy) and/or pelvic floor muscle training, which differ from acupuncture principles. Researchers need to keep a detailed record. Treatments like the principles of acupuncture are not allowed.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eOutcome measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary outcome measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eICIQ-UI-SF\u003c/strong\u003e The International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form. Scores of the scale will be calculated to investigate the incidence of urinary incontinence and the impact of urinary incontinence on patients. It will be used at baseline, and at weeks 6, 12, 18, and 24. The scale is shown in Additional file 4.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcome measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1-h Pad Test\u003c/strong\u003e It is a test to objectively evaluate urinary incontinence. It is measured to assess the change in volume of urine leakage from baseline at weeks 4 and 6.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e72-hour Voiding Diary\u003c/strong\u003e On the basis of not changing life status and urination habits, 72 hours of fluid intake and urination time are continuously recorded every week. It is used to assess the change in mean 72-hour incontinence-episode frequency (IEF) from baseline, and at weeks 1, 2, 4, 6, 12, 18, and 24. The scale is shown in Additional file 5.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEPIC-26\u003c/strong\u003e The Expanded Prostate Cancer Index Composite 26-item version includes three categories of questions aimed to evaluate the prostate function and QoL of patients with prostate cancer in the past 4 weeks. Evaluated at weeks 6, 12, 18, and 24, changes in scores from the baseline will be analyzed. The scale is shown in Additional file 6.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSAS\u003c/strong\u003e Self-Rating Anxiety Scale is a 20-item self-report assessment used to measure anxiety levels, based on the scoring of 4 groups of symptoms: cognitive, autonomic, motor, and central nervous system symptoms. The scores will be evaluated at weeks 6, 12, 18, and 24, and changes in scores from the baseline values will be analyzed. The scale is shown in Additional file 7.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWeekly consumption of pads\u003c/strong\u003e Changing and average weekly consumption of pads at weeks 1, 2, 4, 6, 12, 18, and 24 from the baseline will be calculated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSeverity of urinary incontinence\u003c/strong\u003e It will be evaluated at weeks 6, 12, 18 and 24. The change in the number and percentage of severity ratings from the baseline value will be analyzed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSelf-report assessment of therapeutic effect\u003c/strong\u003e A 4-point scale is used: no help, little help, medium help, and great help [25]. Treatment effects will be evaluated at weeks 6, 12, 18, and 24.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSafety assessment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo exclude any related serious diseases, patients will be asked to undergo necessary inspection before randomization, including vital signs, blood routine, urine routine, biochemical items, ECG. These tests will be performed at the week 6 of the study to evaluate the safety of this trial. If any AEs occur during the trial, patients will be treated as soon as possible.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size calculation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBy enrolling approximately 340 (170 in each group) participants, the study will provide 90% power to detect a between-group difference of 2.5 in reduction of ICI-Q-SF score from baseline using a 2-sided alpha level of 0.05, and assuming a common standard deviation of 6.3 and a dropout rate of 20%. A difference of 2.5 points in the ICI-Q-SF score was selected for sample size calculations, which is indicative of a clinically significant change [25\u0026ndash;27].\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSummary tables (descriptive statistics and/or frequency tables) will be provided for all variables as appropriate. The primary outcome analysis will use the Cochran-Mantel-Haenszel (CMH) test. For continuous variables, means and standard deviations will be presented, unless the variable has a skewed distribution, in which medians, 25th and 75th percentiles will be presented. For other categorical data, between group comparisons will be performed using a Wilcoxon rank-sum test, chi-square test, or Fisher\u0026rsquo;s exact test, as appropriate. AE incidences for each treatment group will be tested by the c2 test or Fisher\u0026rsquo;s exact test as appropriate. All the statistical analysis will be performed using SAS version 9.4 (SAS Institute Inc) with 2-sided tests at a significance level of \u0026lt;0.05.\u003c/p\u003e"},{"header":"Discussion","content":" \u003cp\u003ePPI has a significant impact on the QoL of patients who undergo prostatectomy. It is closely associated with the trauma caused by surgery [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Although urinary incontinence after prostate cancer heals within half a year, the need for active improvement of symptoms and the QoL of patients is widely recognized [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Surgical resection of prostate cancer mainly includes bladder neck, bilateral vas deferens ampulla, bilateral seminal vesicles, and the intact prostate. Although a complete resection of the tumor and avoidance of positive surgical edge can be achieved, often the bladder neck and part of the prostatic apex urethra are removed, which will lead to damage of the urinary control structure. In addition, due to intraoperative bleeding, tumor infiltration, and adhesion, the distal sphincter, fascia, ligament, and pelvic floor muscles may be damaged, which leads to postoperative urinary incontinence [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. The efficacy of acupuncture has been proved by many RCTs [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. A systematic review demonstrated that acupuncture was an appropriate adjunctive therapy for PPI, but the supporting evidence was not sufficient. These limitations included small sample size, greater-than-anticipated withdrawal, the lack of a control group, and unclear statements about randomized allocation. Therefore, more powerful evidence is still needed to verify the efficacy and safety of acupuncture for PPI. We have presented the design of a RCT of verum acupuncture compared with sham acupuncture. Completion of this trial will contribute to verifying the efficacy of acupuncture for the treatment of PPI. This multicenter study covers 13 provinces and cities from south to north in China, we hope that the results will provide robust evidence to support the application of acupuncture in the treatment of postoperative incontinence of prostate cancer.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e The trial has passed the ethical application, and the participants signed an informed consent form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The authors declare that they have no competing interests. And agree to public the protocol and follow-up research data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e National Administration of Traditional Chinese Medicine : 2019 Project of building evidence based practice capacity for TCM(2019XZZX-ZL007).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions:\u003c/strong\u003e Yingjie Jia and Xiaojiang Li drew up the research design. Yao Zhang drafted the protocol and wrote the manuscript in English. Shanqi Guo, Liang Wang and Peiying Yang participated in the design amendment. Yao Zhang, Shanqi Guo, Chaoran Wang and Xiaodi Liu contributed to protocol ethics and trial registration. Yan Liu and Jingbo Zhai revised the details and the language.Yan Liu made the statistical plan. All authors reviewed the manuscript content and approved the final version for submission.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u003c/strong\u003e Thanks to the China Academy of Chinese Medical Sciences of China Center for Evidence Based Traditional Chinese Medicine and Guang\u0026apos;anmen Hospital of China Academy of Chinese Medical Sciences for guiding the project. Thanks to the Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine for Revising research plan.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eSiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021;71:7-33.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLitwin MS, Tan HJ. The diagnosis and treatment of prostate cancer: A review. JAMA. 2017;317:2532-42.\u003c/li\u003e\n \u003cli\u003eChen YC, Lin PH, Jou YY, Lin VC. Surgical treatment for urinary incontinence after prostatectomy: A meta-analysis and systematic review. PLoS One. 2017;12:e0130867.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eBernardes MFVG, Chagas SC, Izidoro LCR, Veloso DFM, Chianca TCM, Mata LRFPD. Impact of urinary incontinence on the quality of life of individuals undergoing radical prostatectomy. Rev Lat Am Enfermagem. 2019;27:e3131.\u003c/li\u003e\n \u003cli\u003eKollberg KS, Thorsteinsdottir T, Wilder\u0026auml;ng U, Hugosson J, Wiklund P, Bjartell A. Social constraints and psychological well-being after prostate cancer: a follow-up at 12 and 24 months after surgery. Psychooncology\u003cem\u003e.\u0026nbsp;\u003c/em\u003e2018;27:668-75.\u003c/li\u003e\n \u003cli\u003ede Lira GHS, Fornari A, Cardoso LF, Aranchipe M, Kretiska C, Rhoden EL.Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial. Int Braz J Urol. 2019 Nov Dec;45(6):1196-1203.\u003c/li\u003e\n \u003cli\u003eErsin A, Demirbas SB, Tarhan F. Short term effects of home-based bladder training and pelvic floor muscle training in symptoms of urinary incontinence. Arch Ital Urol Androl. 2020 Jun 24;92(2). doi: 10.4081/aiua.2020.2.142.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTienforti D, Sacco E, Marangi F, D\u0026apos;Addessi A, Racioppi M, Gulino G, et al. Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int.2012;110:1004-10.\u003c/li\u003e\n \u003cli\u003eHsu LF, Liao YM, Lai FC, Tsai PS. Beneficial effects of biofeedback-assisted pelvic floor muscle training in patients with urinary incontinence after radical prostatectomy: A systematic review and metaanalysis. Int J Nurs Stud. 2016;60:99-111.\u003c/li\u003e\n \u003cli\u003eKannan P, Winser SJ, Fung B, Cheing G. Effectiveness of pelvic floor muscle training alone and in combination with biofeedback, electrical stimulation, or both compared to control for urinary incontinence in men following prostatectomy: Systematic review and meta-analysis. Phys Ther. 2018;98:932-45.\u003c/li\u003e\n \u003cli\u003eNeff D, Guise A, Guralnick ML, Langenstroer P, See WA, Jacobsohn KM, et al. Duloxetine for the treatment of post-prostatectomy stress urinary incontinence. Can Urol Assoc J. 2013;7:E260-2.\u003c/li\u003e\n \u003cli\u003eCollado Serra A, Rubio-Briones J, Puyol Pay\u0026aacute;s M, Iborra Juan I, Ram\u0026oacute;n-Borja JC, Solsona Narb\u0026oacute;n E. Postprostatectomy established stress urinary incontinence treated with duloxetine. Urology. 2011;78:261-6.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eHeah NH, Tan RBW. Management of urethral atrophy after implantation of artificial urinary sphincter: what are the weaknesses? Asian J Androl. 2020 Jan-Feb;22(1):60-63.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eBratu O, Mischianu D, Constantinoiu S. Transobturator urethral suspension surgical treatment of urinary incontinence in men. Chirurgia (Bucur). 2013;108:250-5.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCanvasser NE, Lay AH, Koseoglu E, Morgan MS, Cadeddu JA. Posterior urethral suspension during robot-assisted radical prostatectomy improves early urinary control: a prospective cohort study. J Endourol. 2016;30:1089-94.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eChoi JY, Kim TH, Yang JD, Suh JS, Kwon TG. Adipose- derived regenerative cell injection therapy for postprostatectomy incontinence: A phase I clinical study. Yonsei Med J. 2016;57:1152-8.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eKotecha P, Sahai A, Malde S. Use of duloxetine for postprostatectomy stress urinary incontinence: A systematic review. Eur Urol Focus. 2020;S2405-4569:30165-6.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eNeff D, Guise A, Guralnick ML, Langenstroer P, See WA, Jacobsohn KM, O\u0026apos;Connor RC. Duloxetine for the treatment of post-prostatectomy stress urinary incontinence. Can Urol Assoc J. 2013;7:E260-2.\u003c/li\u003e\n \u003cli\u003eSantos AC Junior, Rodrigues LO, Azevedo DC, Carvalho LM, Fernandes MR, Avelar SO, et al. Artificial urinary sphincter for urinary incontinence after radical prostatectomy: a historical cohort from 2004 to 2015. Int Braz J Urol. 2017;43:150-4.\u003c/li\u003e\n \u003cli\u003eZhong D, Tang W, Geng D, He C. Efficacy and safety of acupuncture therapy for urinary incontinence in women: A systematic review and meta- analysis. Medicine (Baltimore). 2019;98:e17320.\u003c/li\u003e\n \u003cli\u003eThomas LH, Coupe J, Cross LD, Tan AL, Watkins CL. Interventions for treating urinary incontinence after stroke in adults. Cochrane Database Syst Rev. 2019;2:CD004462.\u003c/li\u003e\n \u003cli\u003eLiu Z, Liu Y, Xu H, He L, Chen Y, Fu L, et al. Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence: A randomized clinical trial. JAMA. 2017;317:2493-501.\u003c/li\u003e\n \u003cli\u003eChen H, Liu Y, Wu J, Liang F, Liu Z. Acupuncture for postprostatectomy incontinence: a systematic review. BMJ Support Palliat Care. 2020;bmjspcare-2020-002450.\u003c/li\u003e\n \u003cli\u003eConstable L, Cotterill N, Cooper D, Glazener C, Drake MJ, Forrest M, et al. Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial. Trials. 2018;19:131.\u003c/li\u003e\n \u003cli\u003eLiu Z, Xu H, Chen Y, et al. The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial. Trials. 2013;14:315.\u003c/li\u003e\n \u003cli\u003eNystr\u0026ouml;m E, Sj\u0026ouml;str\u0026ouml;m M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. 2015 Nov;34(8):747-51.\u003c/li\u003e\n \u003cli\u003eJanneke I. M. van Uhm JIM, Vermeer M, Elzevier HW, Noordzij JW, Koldewijn EL, et al. Injectable bulking agent to treat postprostatectomy urinary incontinence: A safety and effectiveness pilot study. Biomed Res Int. 2018;2018:2796967.\u003c/li\u003e\n \u003cli\u003ePelletier J, Cyr SJ, Julien AS, Fradet Y, Lacombe L, Toren P. Contemporary outcomes of palliative transurethral resection of the prostate in patients with locally advanced prostate cancer. Urol Oncol. 2018;36:363.e7-363.e11.\u003c/li\u003e\n \u003cli\u003eSebesta EM, Anderson CB. The surgical management of prostate cancer. Semin Oncol. 2017;44:347-57.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSmither AR, Guralnick ML, Davis NB, See WA. Quantifying the natural history of post-radical prostatectomy incontinence using objective pad test data. BMC Urol. 2007 5;7:2.\u003c/li\u003e\n \u003cli\u003eSallami S. Predictive factors of urinary incontinence after radical prostatectomy: Systematic review. Tunis Med. 2017;95:229-35.\u003c/li\u003e\n \u003cli\u003eHaglind E, Carlsson S, Stranne J, et al. Urinary incontinence and erectile dysfunction after robotic versus open radical prostatectomy: A prospective, controlled, nonrandomised trial. Eur Urol. 2015;68:216-25.\u003c/li\u003e\n \u003cli\u003eJialin Liu, Yuanhao Du, Yacai Hu, Guiping Li, Bo Li, Yiyuan Zhang. Study of acupuncture disease spectrum evidence-based grade division about genitourinary system disease. Tianjin Traditional Chinese Medicine, 2015,32 (09): 542-545.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Acupuncture, Prostatectomy incontinence, Efficacy, Randomized control trial, Study protocol","lastPublishedDoi":"10.21203/rs.3.rs-530412/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-530412/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eUrinary incontinence is a common complication after prostatectomy. Acupuncture is considered an effective treatment for prostatectomy incontinence (PPI), but evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e Twenty hospitals will recruit 340 participants with urinary incontinence after prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow up. Eighteen 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h Pad Test;72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e This trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial Registration: \u003c/strong\u003eThe trial was registered on \u003ca href=\"http://www.chictr.org.cn/\" rel=\"noopener noreferrer\" target=\"_blank\"\u003ewww.Chictr.org.cn\u003c/a\u003e. ChiCTR2100042500. Retrospectively registered on 22 January 2021.\u003c/p\u003e","manuscriptTitle":"Acupuncture for Prostatectomy Incontinence: Study Protocol for A Multicenter Single Blind Randomized Parallel Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-06-21 20:19:42","doi":"10.21203/rs.3.rs-530412/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2021-07-19T16:40:49+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-06-16T00:00:00+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2021-06-15T00:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2021-06-12T00:00:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2021-05-15T07:37:50+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"81d41067-ae70-4fd6-916a-5880743cfaf5","owner":[],"postedDate":"June 21st, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":5138007,"name":"Internal Medicine"},{"id":5138008,"name":"Clinical Pharmacology"}],"tags":[],"updatedAt":"2022-01-04T07:53:24+00:00","versionOfRecord":{"articleIdentity":"rs-530412","link":"https://doi.org/10.1186/s13063-021-05805-5","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2022-01-04 07:53:24","publishedOnDateReadable":"January 4th, 2022"},"versionCreatedAt":"2021-06-21 20:19:42","video":"","vorDoi":"10.1186/s13063-021-05805-5","vorDoiUrl":"https://doi.org/10.1186/s13063-021-05805-5","workflowStages":[]},"version":"v1","identity":"rs-530412","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-530412","identity":"rs-530412","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}