Safety and Efficacy of Transurethral Focal Laser Ablation Versus Transurethral Resection of the Prostate in the Management of Benign Prostatic Obtruction: A Prospective Randomized Study with One Year Follow Up | 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 Safety and Efficacy of Transurethral Focal Laser Ablation Versus Transurethral Resection of the Prostate in the Management of Benign Prostatic Obtruction: A Prospective Randomized Study with One Year Follow Up Mohamed S. Salim salim, Mazen Araby Hassan elsaied, Hassan Sayed Shaker shaker, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7488879/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction and objectives: Laser ablation of prostatic adenoma has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. This study focuses on assessing the safety, efficacy, and postoperative complications of Transurethral Focal Laser Ablation of Prostatic Adenoma (TU-FLAP) versus M-TURP in managing BPH, with a 12-month monitoring. Patients and Methods: 60 BPH cases meeting the inclusion criteria have randomly been assigned into 2 equal groups to undergo either TU-FLAP or M-TURP. Outcomes have been assessed using IPSS, QoL, Qmax, operative time, catheterization ,duration of hospital stay, PVR, PSA, and residual prostate volume. Safety was evaluated based on perioperative and postoperative complications. Results At the one-year follow-up, TU-FLAP resulted in significant clinical improvements, including a 78.56% reduction in IPSS, 58.8% improvement in QoL, 50% decrease in PVR, 20.48% reduction in prostate volume, and a 19.6% decrease in PSA levels. Qmax and IIEF increased by 99.67% and 47.02%, respectively. While M-TURP demonstrated superior outcomes in most functional parameters, TU-FLAP was associated with significantly shorter operative time, reduced hospital stay, and a lower incidence of postoperative complications. Notably, TU-FLAP was free of haematuria, retrograde ejaculation, and incontinence, suggesting a favorable safety profile. In contrast, retrograde ejaculation occurred in 86.96% of patients in the TURP group (Grade I; p < 0.001), representing the only statistically significant difference in adverse events. Conclusions TU-FLAP offers a promising, minimally invasive alternative to M-TURP in BPH management, with favorable outcomes, especially in patients with comorbidities, due to its shorter recovery time and lower complication rate. Transurethral Focal Laser Ablation Prostatic Adenoma Transurethral Prostatectomy Figures Figure 1 Figure 2 Figure 3 INTRODUCTION Benign prostatic hyperplasia is a frequent condition between aging men, often leading to lower urinary tract symptoms (LUTS) that significantly impair quality of life. TURP was long considered the gold standard surgical intervention for prostates ranging from 30 to 80 grams ( 1 ) . Despite its efficacy, TURP is associated with notable risks, including intraoperative bleeding and the potential for fluid absorption leading to dilutional hyponatremia, commonly referred to as TUR syndrome. These risks are particularly pronounced in patients with larger prostates or those on anticoagulant therapy. Additionally, TURP requires considerable surgical expertise and is associated with a steep learning curve ( 2 ) . Transperineal focal laser ablation (TPLA) has emerged as a novel approach, targeting obstructive transitional zone tissue while sparing adjacent structures. This technique achieves debulking by inducing strategic coagulative necrosis, which is subsequently reabsorbed by the body, resulting in reduced prostate volume with minimal impact on urinary continence and sexual function ( 3 ) . Similarly, Rezūm therapy utilizes convective water vapor energy to ablate prostatic tissue. It is an office-based procedure that requires no general anesthesia and has demonstrated durable improvement in LUTS while preserving sexual function ( 4 ) . Despite these advancements, both TPLA and Rezūm remain limited by their restricted availability, the requirement for substantial expertise in transrectal ultrasonography (particularly for TPLA), and the considerable capital investment and ongoing operational costs associated with the equipment. In this context, de TU-FLAP represents the same principle of focal laser ablation as in TPLA; however, the technique was modified to be performed transurethrally rather than transperineally approach, which is a more familiar approach to urologists and requiring no ultrasound knowldge. Unlike existing laser therapies, TU-FLAP is designed to ablate obstructive prostatic adenoma via a transurethral route, without disturbing the urethral mucosa or the ejaculatory ducts. This distinction provides a significant advantage in preserving antegrade ejaculation and reducing the risk of urethral trauma—outcomes often compromised in TURP, HoLEP, and other enucleative procedures. TU-FLAP utilizes real-time endoscopic visualization to deliver precise and targeted energy to the prostatic adenoma, thereby minimizing the risk of direct injury to critical structures such as the urethral sphincter and ejaculatory mechanisms. Moreover, the procedure is typically performed under local anesthesia. This randomized controlled trial was designed to compare TU-FLAP with monopolar TURP in terms of operative metrics, postoperative complications, and patient-reported symptom scores over a one year follow-up duration. MATERIALS AND METHODS Study population and study design This was a prospective randomized trial, performed in our tertiary care center between June 2021 and June 2023. Cases with BPH and a prostate volume below eighty, as determined by transrectal or pelvic ultrasound, were eligible for inclusion if they were indicated for surgical intervention owing to either lower urinary tract symptoms (LUTS) refractory to medical management (IPSS > 20 and Qmax < 15 mL/s) or complications including refractory acute urinary retention, gross hematuria, recurrent urinary tract infections, or renal impairment. On another hand, patients unfit for anesthesia, those with a history of biopsy-proven prostatic or bladder malignancy, prior prostate surgery, urethral stricture, bladder calculi, or a urodynamically confirmed neurogenic bladder were excluded. Using PASS 15 program for sample size calculation, setting power at 90% and alpha error at 0.05, and according to “Bertolo et al, 2021” ( 5 ) the expected mean improvement in Qmax in TURP group = 23.9 ml/sec and in TPLA group = 6 ml/sec Sample size of 20 patients per group will be needed to detect the difference between two groups, depending on that a sample size of minimum of 40 cases with bladder outflow obstruction undergoing surgery (20 cases in each group) were sufficient to achieve research objective. A total of 60 cases have initially been evaluated for eligibility. Of these, three cases did not meet the inclusion criteria, and one case rejected to participate, resulting in 56 cases who were enrolled in the research. The participants have randomly been allocated into 1 of 2 equal groups (1:1) by computerized random assignment software: 28 cases underwent TU-FLAP, and 28 cases had M-TURP. During the monitoring period, three cases from the TU-FLAP group and five cases from the M-TURP group were lost to follow-up. Consequently, 25 cases in the TU-FLAP group and 23 cases in the M-TURP group completed the study and have been involved in the final analysis. Preoperative workup All cases had a standardized preoperative evaluation, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), and quality of life (QoL) assessment. Physical examination included a digital rectal examination (DRE). Additional assessments included uroflowmetry, urinalysis, and urine culture when indicated, as well as measurement of serum prostate-specific antigen (PSA). Pelvic ultrasound was performed to determine post-void residual urine (PVR), and transrectal ultrasound (TRUS) was used to estimate prostate volume. Technique: All monopolar TURP procedures were performed under spinal anesthesia, whereas TU-FLAP procedures were conducted under local anesthesia with intravenous sedation. All operations were performed by a single experienced surgical team, with each surgeon having completed more than 100 comparable procedures prior to study initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin was administered at the time of anesthesia induction. Patients were positioned in lithotomy, and diagnostic urethrocystoscopy was performed prior to intervention. In the TU-FLAP group, a 980-nm diode laser with an end-firing fiber was introduced through the side working channel of a 22 Fr cystoscope. Laser energy was applied at 15 W for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional punctures were performed. Postoperative urethral catheterization was maintained for three to seven days, depending on the volume of treated prostatic tissue and the duration of preoperative urinary retention (Figs. 1 and 2) Postoperative Follow-up Protocol: Postoperative Follow-up Protocol: Efficacy was evaluated using the following parameters: International Prostate Symptom Score (IPSS), quality of life (QoL) score, operative time, maximum urinary flow rate (Qmax),, length of hospital stay, duration of catheterization, post-void residual urine volume (PVR), serum prostate-specific antigen (PSA), and residual prostate volume measured via transrectal ultrasound. The safety profile of each procedure, which was determined by recording the incidence and nature of intraoperative and postoperative complications Statistical Analysis: Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 27.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean ± standard deviation, and categorical variables as frequencies and percentages. Between-group comparisons were conducted using the Student’s t-test for normally distributed continuous variables. The Chi-square (χ²) test or Fisher’s exact test was applied for categorical variables, depending on expected cell counts. A two-tailed p-value < 0.05 was considered statistically significant. RESULTS 25 patients in the TU-FLAP group and 23 in the M-TURP group completed the study and were included in the final analysis. The CONSORT flow diagram outlines the process of enrollment, randomization, and follow-up. The baseline characteristics of both groups—including age, prostate volume, preoperative urinary retention, and PSA levels, were comparable, with statistically insignificant differences detected (p over 0.05), as presented in (Table 1). Regarding perioperative outcomes, there was a statistically significant difference among the M-TURP and TU-FLAP groups in terms of operative time and length of hospital stay, both of which were longer in the M-TURP group. Conversely, catheterization duration was significantly longer in the TU-FLAP group (p < 0.001). These findings are detailed in (Table 2). With respect to perioperative laboratory parameters—including hemoglobin (Hb), sodium (Na), and potassium (K) levels—there were statistically insignificant differences among the TU-FLAP and M-TURP groups, except for a significant postoperative drop in hemoglobin observed in the M-TURP group (p < 0.05) (Table 3). Regarding treatment efficacy, both groups demonstrated significant improvements; however, the M-TURP group showed greater improvements in Qmax, PSA and prostate volume. In contrast, the TU-FLAP group exhibited a significantly greater improvement in IIEF scores. No statistically significant differences were observed between the groups in terms of IPSS scores, post-void residual urine, or QOL. Additionally, the mean values of all assessed parameters showed statistically significant improvement at 12 months within each group. (Table 4). TU-FLAP showed no incidence of haematuria, retrograde ejaculation or incontinence suggesting a favorable safety profile Retrograde ejaculation occurred in 86.96% of patients in the TURP group and was classified as Grade I. This represented the only adverse event with a statistically significant difference between the groups (p < 0.001). Urinary retention and the need for retreatment were observed exclusively in the TU-FLAP group, both classified as moderate complications (Clavien-Dindo Grade IIIa and IIIb, respectively); however, the difference was not statistically significant. No major complications (Grade IV or V) occurred in either group. According to the Clavien-Dindo classification, TU-FLAP demonstrated a comparable, if not superior, safety profile relative to M-TURP, with a lower incidence of functionally significant adverse events (Table 5 ). DISCUSSION Minimally invasive surgical technologies have increasingly redefined the treatment landscape for benign prostatic hyperplasia (BPH), challenging the longstanding role of monopolar transurethral resection of the prostate (TURP) as the gold standard. This paradigm shift is particularly evident among patients with moderate prostatic enlargement and those presenting with significant comorbidities. ( 6 ) In the present randomized controlled trial, transurethral focal laser ablation (TU-FLAP) demonstrated clinical efficacy comparable to TURP, while offering key advantages in perioperative safety and preservation of sexual function. TU-FLAP was associated with significantly shorter operative times and reduced hospital stays, findings attributed to its minimally invasive nature and enhanced intraoperative hemostatic control. These observations are similar to outcomes reported for water vapor thermal therapy (Rezum) ( 7 – 8 ) wherein procedural simplicity, reduced perioperative morbidity, and adaptability to outpatient settings have been highlighted (McVary & Roehrborn, 2019). Such characteristics position TU-FLAP as a viable therapeutic option in settings where surgical risk must be minimized. Both TU-FLAP and TURP achieved substantial and statistically significant improvements in lower urinary tract symptoms (LUTS), as reflected in enhanced peak urinary flow rates (Qmax), reduced International Prostate Symptom Scores (IPSS), and decreased postvoid residual (PVR) volumes. TU-FLAP conferred symptom relief, with sustained improvements observed over the 12-month follow-up period. These results parallel outcomes reported in long-term Rezum registries. For example, McVary et al. (2021) documented sustained IPSS reductions of approximately 50% and corresponding increases in Qmax over four years post-procedure, underscoring the durability of symptom control in focal, non-resective modalities. A particularly noteworthy outcome of this study was the preservation of ejaculatory function following TU-FLAP. No cases of retrograde ejaculation were observed, in stark contrast to the 86.96% incidence noted in the TURP cohort. Given the well-established impact of ejaculatory dysfunction on health-related quality of life in sexually active men, this preservation represents a significant clinical advantage. Rezum therapy has demonstrated similar outcomes, with McVary et al. (2019) reporting ejaculatory function preservation in over 90% of patients one year post-treatment. ( 7 – 9 ) The mechanism underlying these findings is likely related to the targeted nature of both TU-FLAP and Rezum, which avoid substantial disruption of the prostatic urethra and ejaculatory ducts. Although TURP led to a greater mean reduction in prostate volume at 12 months, the correlation between anatomic debulking and symptomatic improvement is variable. As illustrated in the present study and supported by existing data on minimally invasive techniques, clinically meaningful improvements in LUTS can be achieved even with modest reductions in prostate size. This suggests that relief of obstruction in the transition zone, rather than global gland reduction, is the principal determinant of therapeutic success. The safety profile of TU-FLAP further strengthens its clinical applicability. No significant intraoperative hemorrhage, TUR syndrome, or postoperative incontinence was reported. Additionally, TU-FLAP was performed under local anesthesia with sedation, thus extending its utility to patients contraindicated for general or regional anesthesia. This aligns with the minimally invasive, anesthesia-sparing approach emphasized in Rezum protocols. ( 7 ) Emerging evidence on transperineal focal laser ablation (TPLA) supports the broader utility of focal laser techniques in BPH treatment. Recent prospective studies have demonstrated that TPLA leads to significant reductions in IPSS (mean decrease of 12–14 points), improvements in Qmax (mean increase of 4–6 mL/s), and high rates of ejaculatory function preservation (exceeding 85%). (10–11) The complication profile remains favorable, with minimal incidence of bleeding, infection, or incontinence. These findings mirror those of TU-FLAP and suggest that both transurethral and transperineal access routes may yield comparable outcomes, with procedural selection tailored to individual anatomical or clinical considerations. Comparison with recent TPLA data further underscores the clinical value of TU-FLAP. In a prospective study by Walser et al. (2025), TPLA achieved significant IPSS and Qmax improvements at 12 months, there was no significant change in the SHIM score at 6 months (16.0 vs. 16.8; p = 0.59). In a subset of patients for whom 12-month data were available ( 12 ) . These outcomes parallel those of TU-FLAP; however, TU-FLAP demonstrated a shorter mean operative time (30.24 ± 4.95 minutes) and catheterization duration (5.56 ± 0.77 days) compared to TPLA, which reported a median operative time of 31 minutes and catheterization of 7 days (Carnevale et al., 2022) ( 13 ) .These advantages may be attributed to TU-FLAP’s direct endoscopic access and real-time visualization. Another study by Cai et al. (2022) reported favorable outcomes with TPLA in patients with prostate volumes exceeding 60 mL, demonstrating significant symptom improvement and preservation of ejaculatory function in most cases ( 14 ) . While TPLA may be beneficial in anatomically challenging cases, such as those with prominent median lobes or difficult urethral access, TU-FLAP offers greater procedural efficiency and ease of use. Its direct urethral approach with endoscopic visualization supports broader applicability, particularly in outpatient settings.. Limitations of the present study include the relatively modest sample size and limited follow-up duration. Nevertheless, the favorable functional outcomes and safety profile observed with TU-FLAP suggest that it may serve as a valuable alternative to TURP, particularly for patients who prioritize ejaculatory function preservation, outpatient treatment, and rapid postoperative recovery. Future comparative studies involving other minimally invasive modalities, such as Rezum, UroLift, and TPLA, are warranted to further delineate the role of TU-FLAP in contemporary BPH management. CONCLUSIONS Both TU-FLAP and M-TURP proved to be effective surgical options for the treatment of benign prostatic hyperplasia, showing significant clinical improvement at 12 months. M-TURP was associated with superior outcomes in terms of urinary flow rate (Qmax), PSA reduction, and prostate volume reduction. However, TU-FLAP demonstrated a distinct advantage in preserving sexual function, as reflected by significantly higher IIEF scores. Overall, TU-FLAP offers a safer, minimally invasive alternative with better preservation of sexual function, making it a viable option for select patients seeking effective BPH management with faster recovery and preservation of ejaculatory function. Abbreviations BPH: Benign prostatic hyperplasia IPSS: International Prostate Symptom Score TPLA Transperineal Laser Focal Ablation FLA-BPH.......... Focal Laser Ablation for BPH HOLRP.............. Holmium laser resection of prostate LUTS: Lower urinary tract symptoms PSA: Prostate specific antigen PVRU: Post-void residual urine SD: Standard deviation Qmax: Maximal flow rate TURP: Transurethral resection of the prostate Declarations This study has been registered as a clinical trial at ClinicalTrials.gov. The trial registration number has been requested at the time of submission and is currently pending; it will be provided once available Ethics approval This study was approved by the Institutional Review Board of the Faculty of Medicine, Ain Shams University (FMASU 19/2022). Consent to participate Written informed consent was obtained from all participants prior to their inclusion in the study. Human Ethics and Consent to Participate This study was conducted in accordance with the ethical standards of the Faculty of Medicine, Ain Shams University Institutional Review Board, and with the 1964 Helsinki Declaration and its later amendments. Funding This research received no external funding. Conflict of interest The authors declare that they have no conflict of interest. Author Contribution mazen araby , mohammed saied and ahmed tawfiq wrote the main manuscript textashraf prepared figures hassan shaker reviewed the manuscript References Roehrborn CG (2008) Benign prostatic hyperplasia: an overview. Rev Urol. ;10(Suppl 1):S3–S14. PMID: 19043566 Wagenlehner FME, Pilatz A, Weidner W (2015) Complications of transurethral resection of the prostate (TURP). Urol Int 95(1):1–10. https://doi.org/10.1016/j.eururo.2005.12.042 van Kollenburg RA et al (2020) Transperineal laser ablation treatment for lower urinary tract symptoms due to benign prostatic obstruction: protocol for a prospective in vivo pilot study. JMIR Res Protoc 9(1):e15687. https://doi.org/10.2196/15687 McVary KT et al (2016) Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 195(5):1529–1538. https://doi.org/10.1016/j.juro.2015.10.181 Bertolo R, Iacovelli V, Cipriani C, Carilli M, Vittori M, Antonucci M, Maiorino F, Signoretti M, Petta F, Travaglia S, Panei M, Bove P (2023) Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int 131(6):655–663. https://doi.org/10.1111/bju.16008 Christidis D, McGrath S, Perera M, Manning T, Bolton D, Lawrentschuk N (2017) Minimally invasive surgical therapies for benign prostatic hypertrophy: the rise in minimally invasive surgical therapies. Prostate Int 5(2):41–46. https://doi.org/10.1016/j.prnil.2017.01.007 McVary KT, Roehrborn CG (2018) Three-year outcomes of the prospective, randomized controlled Rezūm system study: convective radiofrequency thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Urology 111:1–9. https://doi.org/10.1016/j.urology.2017.10.023 McVary KT et al (2021) Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 206(3):715–724. https://doi.org/10.1097/JU.0000000000001778 McVary KT, Gittelman MC, Goldberg KA et al (2019) Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from randomized controlled study. Urology 126:171–179. https://doi.org/10.1016/j.urology.2018.12.041 Tafuri A et al (2023) Transperineal laser ablation for benign prostatic enlargement: a systematic review and pooled analysis of pilot studies. J Clin Med 12(5):1860. https://doi.org/10.1007/s00345-023-04123-7 Bertolo R et al (2023) Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int 132(1):100–108. https://doi.org/10.1111/bju.16008 Walser EM, Zimmerer R, Nance A, Masood I, Saleem A (2025) Anatomic and clinical effects of focal laser ablation of the prostate on symptomatic benign prostatic hyperplasia. Cancers (Basel) 17(3):475. https://doi.org/10.3390/cancers17030475 Sessa F et al (2022) Transperineal laser ablation of the prostate with EchoLaser™ system: perioperative and short-term functional and sexual outcomes. Front Urol 2:969208. https://doi.org/10.3389/fruro.2022.969208 Cai HJ et al (2022) Ultrasound-guided transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a new minimally invasive interventional therapy. Acta Radiol 63(4):553–558. https://doi.org/10.1177/0284185121100328 Tables Table 1 to 5 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table.docx Cite Share Download PDF Status: Posted Version 1 posted 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-7488879","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":527267664,"identity":"3bcf091d-9d61-4140-a991-e1154af63828","order_by":0,"name":"Mohamed S. Salim salim","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Mohamed","middleName":"S. Salim","lastName":"salim","suffix":""},{"id":527267665,"identity":"176eaee2-bbcd-457f-9609-67ba44b3e17d","order_by":1,"name":"Mazen Araby Hassan elsaied","email":"data:image/png;base64,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","orcid":"","institution":"Ain Shams University","correspondingAuthor":true,"prefix":"","firstName":"Mazen","middleName":"Araby Hassan","lastName":"elsaied","suffix":""},{"id":527267666,"identity":"a60352fb-54fd-4ce1-8a1b-b3f52e24abf8","order_by":2,"name":"Hassan Sayed Shaker shaker","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Hassan","middleName":"Sayed Shaker","lastName":"shaker","suffix":""},{"id":527267667,"identity":"df6b5c50-3f66-436b-ba65-6f059f32b662","order_by":3,"name":"Ahmed Tawfick Hassan hassan","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Ahmed","middleName":"Tawfick Hassan","lastName":"hassan","suffix":""},{"id":527267668,"identity":"9c926b59-6869-4321-9697-e6973646e81b","order_by":4,"name":"Ashraf M. Satour satour","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Ashraf","middleName":"M. Satour","lastName":"satour","suffix":""},{"id":527267672,"identity":"21ff9a53-48ab-487a-accd-2f6e42973823","order_by":5,"name":"Ahmed Farouk Salim salim","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Ahmed","middleName":"Farouk Salim","lastName":"salim","suffix":""}],"badges":[],"createdAt":"2025-08-29 13:08:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7488879/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7488879/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":93340121,"identity":"26c5b951-4fcb-48b9-b5f0-b029a10e193f","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"doc","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":79360,"visible":true,"origin":"","legend":"","description":"","filename":"finalManuscriptwithoutauthordetails1792025.doc","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/72070a4aeb90391d57b3843f.doc"},{"id":93340127,"identity":"b425793b-cc6a-4fb2-b06b-de9a1d4a0914","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":232825,"visible":true,"origin":"","legend":"","description":"","filename":"Figures.docx","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/bb6636a893516f38c1f9f450.docx"},{"id":93340981,"identity":"a304e035-707f-4659-933b-e8b547a05e56","added_by":"auto","created_at":"2025-10-12 14:37:03","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":25978,"visible":true,"origin":"","legend":"","description":"","filename":"Table.docx","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/f5673313d747d7810784b621.docx"},{"id":93340122,"identity":"145519a0-4c30-4eca-8b8c-ad6076bf2f8b","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"json","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":7585,"visible":true,"origin":"","legend":"","description":"","filename":"a671b48867a6481da38a7b3f9f8d35d6.json","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/50925a4d1a8e180f6f920355.json"},{"id":93340125,"identity":"c464cbec-eac2-49f9-bd4c-f8d796eec23b","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"xml","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":90420,"visible":true,"origin":"","legend":"","description":"","filename":"a671b48867a6481da38a7b3f9f8d35d61enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/674cc131a7ca0f559b969096.xml"},{"id":93340984,"identity":"84506c13-28b1-4365-bd03-e6c2441fd29b","added_by":"auto","created_at":"2025-10-12 14:37:03","extension":"png","order_by":8,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":79262,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/5df27b3f3702ba0ddf95ca11.png"},{"id":93342700,"identity":"7767cd3b-db14-4cdb-8f67-b04904595316","added_by":"auto","created_at":"2025-10-12 14:45:03","extension":"png","order_by":9,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":25864,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/2767fa012de35b813f367e51.png"},{"id":93340129,"identity":"458dd82c-1c47-4fa1-9af1-55c7847a45f3","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"png","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":13054,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/4f546657db0654e52cd5d282.png"},{"id":93340130,"identity":"76c5b60f-7a67-40e6-b146-b67ae2f488de","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"xml","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":89871,"visible":true,"origin":"","legend":"","description":"","filename":"a671b48867a6481da38a7b3f9f8d35d61structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/de2eacd0ab91a09f33d685aa.xml"},{"id":93340131,"identity":"a9990f0c-e8f2-4bcf-8094-f7d8036dd7a7","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"html","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":98565,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/a775bd656a6b61915be28f2a.html"},{"id":93340120,"identity":"24311a4f-4aed-46d1-9c8d-17aff5f59f1b","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":158931,"visible":true,"origin":"","legend":"\u003cp\u003eEnd firing laser fibre\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/bf222e4629b17759722c0d3a.jpeg"},{"id":93340128,"identity":"e29c2e27-0ad3-47dd-a96c-9995956a46d1","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":20130,"visible":true,"origin":"","legend":"\u003cp\u003eDiode laser device setting\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/7a1cf9a58f6d3b89e4ab664f.jpeg"},{"id":93340119,"identity":"e872f3d7-8b1a-47f5-a7bc-f56189435e60","added_by":"auto","created_at":"2025-10-12 14:29:03","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":38479,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT flow: 56 eligible patients were randomized equally to TU-FLAP (n=28) and M-TURP (n=28) after excluding 4.\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/8750e07d94a03cdfb5a2ed8a.png"},{"id":105903785,"identity":"75f79e49-c749-4e5d-a144-fcabd8e00752","added_by":"auto","created_at":"2026-04-01 09:53:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":713255,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/0cfdea41-de37-4a76-b9fa-b0aede8d8781.pdf"},{"id":93340983,"identity":"3bf506df-302b-4c20-8079-d3faf9348116","added_by":"auto","created_at":"2025-10-12 14:37:03","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":25978,"visible":true,"origin":"","legend":"","description":"","filename":"Table.docx","url":"https://assets-eu.researchsquare.com/files/rs-7488879/v1/1e2519704d70b28f9e3a0858.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eSafety and Efficacy of Transurethral Focal Laser Ablation Versus Transurethral Resection of the Prostate in the Management of Benign Prostatic Obtruction: A Prospective Randomized Study with One Year Follow Up\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eBenign prostatic hyperplasia is a frequent condition between aging men, often leading to lower urinary tract symptoms (LUTS) that significantly impair quality of life. TURP was long considered the gold standard surgical intervention for prostates ranging from 30 to 80 grams \u003csup\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/sup\u003e. Despite its efficacy, TURP is associated with notable risks, including intraoperative bleeding and the potential for fluid absorption leading to dilutional hyponatremia, commonly referred to as TUR syndrome. These risks are particularly pronounced in patients with larger prostates or those on anticoagulant therapy. Additionally, TURP requires considerable surgical expertise and is associated with a steep learning curve\u003csup\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e .\u003c/p\u003e\u003cp\u003eTransperineal focal laser ablation (TPLA) has emerged as a novel approach, targeting obstructive transitional zone tissue while sparing adjacent structures. This technique achieves debulking by inducing strategic coagulative necrosis, which is subsequently reabsorbed by the body, resulting in reduced prostate volume with minimal impact on urinary continence and sexual function\u003csup\u003e(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/sup\u003e. Similarly, Rezūm therapy utilizes convective water vapor energy to ablate prostatic tissue. It is an office-based procedure that requires no general anesthesia and has demonstrated durable improvement in LUTS while preserving sexual function \u003csup\u003e(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/sup\u003e .\u003c/p\u003e\u003cp\u003eDespite these advancements, both TPLA and Rezūm remain limited by their restricted availability, the requirement for substantial expertise in transrectal ultrasonography (particularly for TPLA), and the considerable capital investment and ongoing operational costs associated with the equipment.\u003c/p\u003e\u003cp\u003eIn this context, de TU-FLAP represents the same principle of focal laser ablation as in TPLA; however, the technique was modified to be performed transurethrally rather than transperineally approach, which is a more familiar approach to urologists and requiring no ultrasound knowldge. Unlike existing laser therapies, TU-FLAP is designed to ablate obstructive prostatic adenoma via a transurethral route, without disturbing the urethral mucosa or the ejaculatory ducts. This distinction provides a significant advantage in preserving antegrade ejaculation and reducing the risk of urethral trauma\u0026mdash;outcomes often compromised in TURP, HoLEP, and other enucleative procedures.\u003c/p\u003e\u003cp\u003eTU-FLAP utilizes real-time endoscopic visualization to deliver precise and targeted energy to the prostatic adenoma, thereby minimizing the risk of direct injury to critical structures such as the urethral sphincter and ejaculatory mechanisms. Moreover, the procedure is typically performed under local anesthesia.\u003c/p\u003e\u003cp\u003eThis randomized controlled trial was designed to compare TU-FLAP with monopolar TURP in terms of operative metrics, postoperative complications, and patient-reported symptom scores over a one year follow-up duration.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy population and study design\u003c/h2\u003e\u003cp\u003eThis was a prospective randomized trial, performed in our tertiary care center between June 2021 and June 2023.\u003c/p\u003e\u003cp\u003eCases with BPH and a prostate volume below eighty, as determined by transrectal or pelvic ultrasound, were eligible for inclusion if they were indicated for surgical intervention owing to either lower urinary tract symptoms (LUTS) refractory to medical management (IPSS\u0026thinsp;\u0026gt;\u0026thinsp;20 and Qmax\u0026thinsp;\u0026lt;\u0026thinsp;15 mL/s) or complications including refractory acute urinary retention, gross hematuria, recurrent urinary tract infections, or renal impairment. On another hand, patients unfit for anesthesia, those with a history of biopsy-proven prostatic or bladder malignancy, prior prostate surgery, urethral stricture, bladder calculi, or a urodynamically confirmed neurogenic bladder were excluded. Using PASS 15 program for sample size calculation, setting power at 90% and alpha error at 0.05, and according to \u0026ldquo;Bertolo et al, 2021\u0026rdquo; \u003csup\u003e(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/sup\u003e the expected mean improvement in Qmax in TURP group\u0026thinsp;=\u0026thinsp;23.9 ml/sec and in TPLA group\u0026thinsp;=\u0026thinsp;6 ml/sec\u003c/p\u003e\u003cp\u003eSample size of 20 patients per group will be needed to detect the difference between two groups, depending on that a sample size of minimum of 40 cases with bladder outflow obstruction undergoing surgery (20 cases in each group) were sufficient to achieve research objective. A total of 60 cases have initially been evaluated for eligibility. Of these, three cases did not meet the inclusion criteria, and one case rejected to participate, resulting in 56 cases who were enrolled in the research. The participants have randomly been allocated into 1 of 2 equal groups (1:1) by computerized random assignment software: 28 cases underwent TU-FLAP, and 28 cases had M-TURP. During the monitoring period, three cases from the TU-FLAP group and five cases from the M-TURP group were lost to follow-up. Consequently, 25 cases in the TU-FLAP group and 23 cases in the M-TURP group completed the study and have been involved in the final analysis.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003ePreoperative workup\u003c/h3\u003e\n\u003cp\u003eAll cases had a standardized preoperative evaluation, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), and quality of life (QoL) assessment. Physical examination included a digital rectal examination (DRE). Additional assessments included uroflowmetry, urinalysis, and urine culture when indicated, as well as measurement of serum prostate-specific antigen (PSA). Pelvic ultrasound was performed to determine post-void residual urine (PVR), and transrectal ultrasound (TRUS) was used to estimate prostate volume.\u003c/p\u003e\n\u003ch3\u003eTechnique:\u003c/h3\u003e\n\u003cp\u003eAll monopolar TURP procedures were performed under spinal anesthesia, whereas TU-FLAP procedures were conducted under local anesthesia with intravenous sedation. All operations were performed by a single experienced surgical team, with each surgeon having completed more than 100 comparable procedures prior to study initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin was administered at the time of anesthesia induction. Patients were positioned in lithotomy, and diagnostic urethrocystoscopy was performed prior to intervention.\u003c/p\u003e\u003cp\u003eIn the TU-FLAP group, a 980-nm diode laser with an end-firing fiber was introduced through the side working channel of a 22 Fr cystoscope. Laser energy was applied at 15 W for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional punctures were performed. Postoperative urethral catheterization was maintained for three to seven days, depending on the volume of treated prostatic tissue and the duration of preoperative urinary retention (Figs.\u0026nbsp;1 and 2)\u003c/p\u003e\n\u003ch3\u003ePostoperative Follow-up Protocol:\u003c/h3\u003e\n\u003cdiv class=\"Heading\"\u003ePostoperative Follow-up Protocol:\u003c/div\u003e\u003cp\u003eEfficacy was evaluated using the following parameters: International Prostate Symptom Score (IPSS), quality of life (QoL) score, operative time, maximum urinary flow rate (Qmax),, length of hospital stay, duration of catheterization, post-void residual urine volume (PVR), serum prostate-specific antigen (PSA), and residual prostate volume measured via transrectal ultrasound. The safety profile of each procedure, which was determined by recording the incidence and nature of intraoperative and postoperative complications\u003c/p\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eStatistical Analysis:\u003c/h2\u003e\u003cp\u003eStatistical analysis was performed using IBM SPSS Statistics for Windows, Version 27.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation, and categorical variables as frequencies and percentages. Between-group comparisons were conducted using the Student\u0026rsquo;s t-test for normally distributed continuous variables. The Chi-square (χ\u0026sup2;) test or Fisher\u0026rsquo;s exact test was applied for categorical variables, depending on expected cell counts. A two-tailed p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003e25 patients in the TU-FLAP group and 23 in the M-TURP group completed the study and were included in the final analysis. The CONSORT flow diagram outlines the process of enrollment, randomization, and follow-up.\u003c/p\u003e\u003cp\u003eThe baseline characteristics of both groups\u0026mdash;including age, prostate volume, preoperative urinary retention, and PSA levels, were comparable, with statistically insignificant differences detected (p over 0.05), as presented in (Table\u0026nbsp;1). Regarding perioperative outcomes, there was a statistically significant difference among the M-TURP and TU-FLAP groups in terms of operative time and length of hospital stay, both of which were longer in the M-TURP group. Conversely, catheterization duration was significantly longer in the TU-FLAP group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). These findings are detailed in (Table\u0026nbsp;2). With respect to perioperative laboratory parameters\u0026mdash;including hemoglobin (Hb), sodium (Na), and potassium (K) levels\u0026mdash;there were statistically insignificant differences among the TU-FLAP and M-TURP groups, except for a significant postoperative drop in hemoglobin observed in the M-TURP group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) (Table\u0026nbsp;3). Regarding treatment efficacy, both groups demonstrated significant improvements; however, the M-TURP group showed greater improvements in Qmax, PSA and prostate volume. In contrast, the TU-FLAP group exhibited a significantly greater improvement in IIEF scores. No statistically significant differences were observed between the groups in terms of IPSS scores, post-void residual urine, or QOL. Additionally, the mean values of all assessed parameters showed statistically significant improvement at 12 months within each group. (Table\u0026nbsp;4). TU-FLAP showed no incidence of haematuria, retrograde ejaculation or incontinence suggesting a favorable safety profile Retrograde ejaculation occurred in 86.96% of patients in the TURP group and was classified as Grade I. This represented the only adverse event with a statistically significant difference between the groups (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Urinary retention and the need for retreatment were observed exclusively in the TU-FLAP group, both classified as moderate complications (Clavien-Dindo Grade IIIa and IIIb, respectively); however, the difference was not statistically significant. No major complications (Grade IV or V) occurred in either group. According to the Clavien-Dindo classification, TU-FLAP demonstrated a comparable, if not superior, safety profile relative to M-TURP, with a lower incidence of functionally significant adverse events (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eMinimally invasive surgical technologies have increasingly redefined the treatment landscape for benign prostatic hyperplasia (BPH), challenging the longstanding role of monopolar transurethral resection of the prostate (TURP) as the gold standard. This paradigm shift is particularly evident among patients with moderate prostatic enlargement and those presenting with significant comorbidities. \u003csup\u003e(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/sup\u003e In the present randomized controlled trial, transurethral focal laser ablation (TU-FLAP) demonstrated clinical efficacy comparable to TURP, while offering key advantages in perioperative safety and preservation of sexual function.\u003c/p\u003e\u003cp\u003eTU-FLAP was associated with significantly shorter operative times and reduced hospital stays, findings attributed to its minimally invasive nature and enhanced intraoperative hemostatic control. These observations are similar to outcomes reported for water vapor thermal therapy (Rezum) \u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/sup\u003e wherein procedural simplicity, reduced perioperative morbidity, and adaptability to outpatient settings have been highlighted (McVary \u0026amp; Roehrborn, 2019). Such characteristics position TU-FLAP as a viable therapeutic option in settings where surgical risk must be minimized.\u003c/p\u003e\u003cp\u003eBoth TU-FLAP and TURP achieved substantial and statistically significant improvements in lower urinary tract symptoms (LUTS), as reflected in enhanced peak urinary flow rates (Qmax), reduced International Prostate Symptom Scores (IPSS), and decreased postvoid residual (PVR) volumes. TU-FLAP conferred symptom relief, with sustained improvements observed over the 12-month follow-up period. These results parallel outcomes reported in long-term Rezum registries. For example, McVary et al. (2021) documented sustained IPSS reductions of approximately 50% and corresponding increases in Qmax over four years post-procedure, underscoring the durability of symptom control in focal, non-resective modalities.\u003c/p\u003e\u003cp\u003eA particularly noteworthy outcome of this study was the preservation of ejaculatory function following TU-FLAP. No cases of retrograde ejaculation were observed, in stark contrast to the 86.96% incidence noted in the TURP cohort. Given the well-established impact of ejaculatory dysfunction on health-related quality of life in sexually active men, this preservation represents a significant clinical advantage. Rezum therapy has demonstrated similar outcomes, with McVary et al. (2019) reporting ejaculatory function preservation in over 90% of patients one year post-treatment.\u003csup\u003e(\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/sup\u003e The mechanism underlying these findings is likely related to the targeted nature of both TU-FLAP and Rezum, which avoid substantial disruption of the prostatic urethra and ejaculatory ducts.\u003c/p\u003e\u003cp\u003eAlthough TURP led to a greater mean reduction in prostate volume at 12 months, the correlation between anatomic debulking and symptomatic improvement is variable. As illustrated in the present study and supported by existing data on minimally invasive techniques, clinically meaningful improvements in LUTS can be achieved even with modest reductions in prostate size. This suggests that relief of obstruction in the transition zone, rather than global gland reduction, is the principal determinant of therapeutic success.\u003c/p\u003e\u003cp\u003eThe safety profile of TU-FLAP further strengthens its clinical applicability. No significant intraoperative hemorrhage, TUR syndrome, or postoperative incontinence was reported. Additionally, TU-FLAP was performed under local anesthesia with sedation, thus extending its utility to patients contraindicated for general or regional anesthesia. This aligns with the minimally invasive, anesthesia-sparing approach emphasized in Rezum protocols. \u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eEmerging evidence on transperineal focal laser ablation (TPLA) supports the broader utility of focal laser techniques in BPH treatment. Recent prospective studies have demonstrated that TPLA leads to significant reductions in IPSS (mean decrease of 12\u0026ndash;14 points), improvements in Qmax (mean increase of 4\u0026ndash;6 mL/s), and high rates of ejaculatory function preservation (exceeding 85%).\u003csup\u003e(10\u0026ndash;11)\u003c/sup\u003e The complication profile remains favorable, with minimal incidence of bleeding, infection, or incontinence. These findings mirror those of TU-FLAP and suggest that both transurethral and transperineal access routes may yield comparable outcomes, with procedural selection tailored to individual anatomical or clinical considerations.\u003c/p\u003e\u003cp\u003eComparison with recent TPLA data further underscores the clinical value of TU-FLAP. In a prospective study by Walser et al. (2025), TPLA achieved significant IPSS and Qmax improvements at 12 months, there was no significant change in the SHIM score at 6 months (16.0 vs. 16.8; p\u0026thinsp;=\u0026thinsp;0.59). In a subset of patients for whom 12-month data were available\u003csup\u003e(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/sup\u003e. These outcomes parallel those of TU-FLAP; however, TU-FLAP demonstrated a shorter mean operative time (30.24\u0026thinsp;\u0026plusmn;\u0026thinsp;4.95 minutes) and catheterization duration (5.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.77 days) compared to TPLA, which reported a median operative time of 31 minutes and catheterization of 7 days (Carnevale et al., 2022)\u003csup\u003e(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/sup\u003e.These advantages may be attributed to TU-FLAP\u0026rsquo;s direct endoscopic access and real-time visualization.\u003c/p\u003e\u003cp\u003eAnother study by Cai et al. (2022) reported favorable outcomes with TPLA in patients with prostate volumes exceeding 60 mL, demonstrating significant symptom improvement and preservation of ejaculatory function in most cases\u003csup\u003e(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/sup\u003e. While TPLA may be beneficial in anatomically challenging cases, such as those with prominent median lobes or difficult urethral access, TU-FLAP offers greater procedural efficiency and ease of use. Its direct urethral approach with endoscopic visualization supports broader applicability, particularly in outpatient settings..\u003c/p\u003e\u003cp\u003eLimitations of the present study include the relatively modest sample size and limited follow-up duration. Nevertheless, the favorable functional outcomes and safety profile observed with TU-FLAP suggest that it may serve as a valuable alternative to TURP, particularly for patients who prioritize ejaculatory function preservation, outpatient treatment, and rapid postoperative recovery. Future comparative studies involving other minimally invasive modalities, such as Rezum, UroLift, and TPLA, are warranted to further delineate the role of TU-FLAP in contemporary BPH management.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eBoth TU-FLAP and M-TURP proved to be effective surgical options for the treatment of benign prostatic hyperplasia, showing significant clinical improvement at 12 months. M-TURP was associated with superior outcomes in terms of urinary flow rate (Qmax), PSA reduction, and prostate volume reduction. However, TU-FLAP demonstrated a distinct advantage in preserving sexual function, as reflected by significantly higher IIEF scores.\u003c/p\u003e\u003cp\u003eOverall, TU-FLAP offers a safer, minimally invasive alternative with better preservation of sexual function, making it a viable option for select patients seeking effective BPH management with faster recovery and preservation of ejaculatory function.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBPH: Benign prostatic hyperplasia\u003c/p\u003e\n\u003cp\u003eIPSS: International Prostate Symptom Score\u003c/p\u003e\n\u003cp\u003eTPLA\u0026nbsp;Transperineal Laser Focal Ablation\u003c/p\u003e\n\u003cp\u003eFLA-BPH..........\u0026nbsp;Focal Laser Ablation for BPH\u003c/p\u003e\n\u003cp\u003eHOLRP..............\u0026nbsp;Holmium laser resection of prostate\u003c/p\u003e\n\u003cp\u003eLUTS: Lower urinary tract symptoms\u003c/p\u003e\n\u003cp\u003ePSA: Prostate specific antigen\u003c/p\u003e\n\u003cp\u003ePVRU: Post-void residual urine\u003c/p\u003e\n\u003cp\u003eSD: Standard deviation\u003c/p\u003e\n\u003cp\u003eQmax: Maximal flow rate\u003c/p\u003e\n\u003cp\u003eTURP: Transurethral resection of the prostate\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eThis study has been registered as a clinical trial at ClinicalTrials.gov.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;The trial registration number has been requested at the time of submission and is currently pending; it will be provided once available\u003c/p\u003e\n\u003cp\u003eEthics approval\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Institutional Review Board of the Faculty of Medicine, Ain Shams University (FMASU 19/2022).\u003c/p\u003e\n\u003cp\u003eConsent to participate\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from all participants prior to their inclusion in the study.\u003c/p\u003e\n\u003cp\u003eHuman Ethics and Consent to Participate\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the ethical standards of the Faculty of Medicine, Ain Shams University Institutional Review Board, and with the 1964 Helsinki Declaration and its later amendments.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eThis research received no external funding.\u003c/p\u003e\n\u003cp\u003eConflict of interest\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003emazen araby , mohammed saied and ahmed tawfiq wrote the main manuscript textashraf prepared figures hassan shaker reviewed the manuscript\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eRoehrborn CG (2008) Benign prostatic hyperplasia: an overview. Rev Urol. ;10(Suppl 1):S3\u0026ndash;S14. PMID: 19043566\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWagenlehner FME, Pilatz A, Weidner W (2015) Complications of transurethral resection of the prostate (TURP). Urol Int 95(1):1\u0026ndash;10. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.eururo.2005.12.042\u003c/span\u003e\u003cspan address=\"10.1016/j.eururo.2005.12.042\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003evan Kollenburg RA et al (2020) Transperineal laser ablation treatment for lower urinary tract symptoms due to benign prostatic obstruction: protocol for a prospective in vivo pilot study. JMIR Res Protoc 9(1):e15687. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.2196/15687\u003c/span\u003e\u003cspan address=\"10.2196/15687\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMcVary KT et al (2016) Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 195(5):1529\u0026ndash;1538. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.juro.2015.10.181\u003c/span\u003e\u003cspan address=\"10.1016/j.juro.2015.10.181\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBertolo R, Iacovelli V, Cipriani C, Carilli M, Vittori M, Antonucci M, Maiorino F, Signoretti M, Petta F, Travaglia S, Panei M, Bove P (2023) Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int 131(6):655\u0026ndash;663. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/bju.16008\u003c/span\u003e\u003cspan address=\"10.1111/bju.16008\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChristidis D, McGrath S, Perera M, Manning T, Bolton D, Lawrentschuk N (2017) Minimally invasive surgical therapies for benign prostatic hypertrophy: the rise in minimally invasive surgical therapies. Prostate Int 5(2):41\u0026ndash;46. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.prnil.2017.01.007\u003c/span\u003e\u003cspan address=\"10.1016/j.prnil.2017.01.007\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMcVary KT, Roehrborn CG (2018) Three-year outcomes of the prospective, randomized controlled Rezūm system study: convective radiofrequency thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Urology 111:1\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.urology.2017.10.023\u003c/span\u003e\u003cspan address=\"10.1016/j.urology.2017.10.023\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMcVary KT et al (2021) Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 206(3):715\u0026ndash;724. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1097/JU.0000000000001778\u003c/span\u003e\u003cspan address=\"10.1097/JU.0000000000001778\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMcVary KT, Gittelman MC, Goldberg KA et al (2019) Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from randomized controlled study. Urology 126:171\u0026ndash;179. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.urology.2018.12.041\u003c/span\u003e\u003cspan address=\"10.1016/j.urology.2018.12.041\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTafuri A et al (2023) Transperineal laser ablation for benign prostatic enlargement: a systematic review and pooled analysis of pilot studies. J Clin Med 12(5):1860. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00345-023-04123-7\u003c/span\u003e\u003cspan address=\"10.1007/s00345-023-04123-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBertolo R et al (2023) Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int 132(1):100\u0026ndash;108. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/bju.16008\u003c/span\u003e\u003cspan address=\"10.1111/bju.16008\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWalser EM, Zimmerer R, Nance A, Masood I, Saleem A (2025) Anatomic and clinical effects of focal laser ablation of the prostate on symptomatic benign prostatic hyperplasia. Cancers (Basel) 17(3):475. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3390/cancers17030475\u003c/span\u003e\u003cspan address=\"10.3390/cancers17030475\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSessa F et al (2022) Transperineal laser ablation of the prostate with EchoLaser\u0026trade; system: perioperative and short-term functional and sexual outcomes. Front Urol 2:969208. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3389/fruro.2022.969208\u003c/span\u003e\u003cspan address=\"10.3389/fruro.2022.969208\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCai HJ et al (2022) Ultrasound-guided transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a new minimally invasive interventional therapy. Acta Radiol 63(4):553\u0026ndash;558. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1177/0284185121100328\u003c/span\u003e\u003cspan address=\"10.1177/0284185121100328\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 to 5 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Transurethral Focal Laser Ablation, Prostatic Adenoma, Transurethral Prostatectomy","lastPublishedDoi":"10.21203/rs.3.rs-7488879/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7488879/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction and objectives:\u003c/h2\u003e\u003cp\u003eLaser ablation of prostatic adenoma has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. This study focuses on assessing the safety, efficacy, and postoperative complications of Transurethral Focal Laser Ablation of Prostatic Adenoma (TU-FLAP) versus M-TURP in managing BPH, with a 12-month monitoring.\u003c/p\u003e\u003ch2\u003ePatients and Methods:\u003c/h2\u003e\u003cp\u003e60 BPH cases meeting the inclusion criteria have randomly been assigned into 2 equal groups to undergo either TU-FLAP or M-TURP. Outcomes have been assessed using IPSS, QoL, Qmax, operative time, catheterization ,duration of hospital stay, PVR, PSA, and residual prostate volume. Safety was evaluated based on perioperative and postoperative complications.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eAt the one-year follow-up, TU-FLAP resulted in significant clinical improvements, including a 78.56% reduction in IPSS, 58.8% improvement in QoL, 50% decrease in PVR, 20.48% reduction in prostate volume, and a 19.6% decrease in PSA levels. Qmax and IIEF increased by 99.67% and 47.02%, respectively. While M-TURP demonstrated superior outcomes in most functional parameters, TU-FLAP was associated with significantly shorter operative time, reduced hospital stay, and a lower incidence of postoperative complications. Notably, TU-FLAP was free of haematuria, retrograde ejaculation, and incontinence, suggesting a favorable safety profile. In contrast, retrograde ejaculation occurred in 86.96% of patients in the TURP group (Grade I; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), representing the only statistically significant difference in adverse events.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eTU-FLAP offers a promising, minimally invasive alternative to M-TURP in BPH management, with favorable outcomes, especially in patients with comorbidities, due to its shorter recovery time and lower complication rate.\u003c/p\u003e","manuscriptTitle":"Safety and Efficacy of Transurethral Focal Laser Ablation Versus Transurethral Resection of the Prostate in the Management of Benign Prostatic Obtruction: A Prospective Randomized Study with One Year Follow Up","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-12 14:28:58","doi":"10.21203/rs.3.rs-7488879/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"94eac5bf-f9a4-4c67-93a2-7ccb4e26f06a","owner":[],"postedDate":"October 12th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-20T23:23:39+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-12 14:28:58","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7488879","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7488879","identity":"rs-7488879","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
Text is read by the "Ask this paper" AI Q&A widget below.
Extraction quality varies by source — PMC NXML preserves structure
cleanly, OA-HTML may include some navigation residue, and OA-PDF can
have broken hyphenation. The publisher copy
(via DOI)
is the canonical version.