Efficacy of High-Intensity Focused Ultrasound in Urinary and Fecal Symptoms Caused by Rectocele and Cystocele

HIFU (high-intensity focused ultrasound) technology has grown significantly as an emerging method in the field of medical treatment in recent decades.[ 1 ] In this method, high-intensity ultrasound waves deliver their energy to the target tissue directly at a predetermined distance and without damaging the adjacent tissues.[ 2 ] This advantage has made it to be welcomed in several medical fields such as surgery, urology, gynecology, obstetrics, and dermatology in addition to the significant role of HIFU in cancer treatment and showed effectiveness.[ 3 4 5 ] The main advantage of HIFU is the concentration of sound waves in the desired target so that the radiation of high-intensity ultrasound waves quickly increases the heat inside the tissue.[ 6 ] This treatment method can be an alternative to many surgical treatments. The principle of HIFU mechanism is to induce cell damage and reduce the volume of the target area with the help of coagulation resulting from subtle and fast microthermal lesions, which are created by high-frequency ultrasound waves in the target tissue.[ 7 ] Since HIFU is considered a noninvasive treatment, it has very few side effects and has far less side effects than laparoscopic treatment methods and open surgery.[ 8 ] Cystocele or bladder protrusion occurs when the bladder descends into the vagina.[ 9 ] A prolapsed or herniated bladder has a negative effect on people’s quality of life and affects their daily and sexual experience.[ 10 ] Rectocele is a type of pelvic organ prolapse which is defined by rectal hernia inside the vaginal canal through a weakness in the wall between the rectum and vagina. This abnormality can also cause several discomforts in the daily life of a woman.[ 11 ] Considering the low side effects and favorable effectiveness of the HIFU treatment method, which has been proven in many diseases, it seems that this method can be used in the treatment of urinary and fecal symptoms caused by rectocele and cystocele. In this matter, no comprehensive study has been done so far. In this study, we intend to investigate the effectiveness of the HIFU treatment method in the treatment of urinary and fecal symptoms caused by cystocele and rectocele and investigate its side effects.

In total, after sampling, we enrolled 50 patients in each group. There was no significant difference regarding baseline demographic information and baseline scores of questionnaires ( P value > 0.05). After treatment, only two patients in the HIFU group experienced mild superficial burn injury (first degree), which healed with no complication in the following week. The mean scores of FSFI questionnaire and PFDI questionnaire in both treatment groups are shown in Tables 1 - 4 . As can be seen, both Kegel exercises and HIFU improved significantly the scores of all sections of FSFI and PFDI questionnaires ( P value < 0.05). Our data in comparison of Kegel exercises versus HIFU therapy indicated no significant difference between two treatment groups [ Table 5 ]. Demographic information of participants in both treatment groups Results of FSFI questionnaire at the beginning of study and 2 months and 6 months after in the group of patients who underwent Kegel exercises * t -test Results of FSFI questionnaire at the beginning of study and 2 months and 6 months after in the group of patients who underwent HIFU therapy * t -test Results of PFDI questionnaire at the beginning of study and 2 months and 6 months after in the group of patients who underwent Kegel exercises * t -test Results of PFDI questionnaire at the beginning of study and 2 months and 6 months after in the group of patients who underwent HIFU therapy * t -test

In gynecology, especially after cesarean surgery, pelvic floor dysfunction—which includes pelvic organ prolapse and stress urinary incontinence—is one of the most common and dangerous complications.[ 17 ] One or both of the pelvic compartments may experience a prolapse of the female pelvic organs. The bladder and urethra are in the anterior compartment, while the rectum and anus are in the posterior compartment. Through its anterior and posterior vaginal walls, the vagina divides these two compartments.[ 18 ] Tissue ablation by HIFU, a noninvasive method for the local treatment of solid tumors, has become more popular in recent years.[ 19 ] These also include gynecological features like adenomyosis, breast fibroadenoma, uterine fibroids, and even breast cancer.[ 20 ] HIFU has been evaluated for over 10 years and has been found to be a safe and effective treatment option with minimal invasiveness and minimal clinical impact on a patient’s life style.[ 21 ] External ultrasonic energy is applied to a lesion during HIFU, which results in coagulation necrosis in the target area. As a result, the lesions are entirely destroyed in situ , leaving the skin intact.[ 22 ] In another study, Suzuki et al . used HIFU in urinary incontinency. Many patients experienced improvement in urinary incontinence relatively early after HIFU, and ICIQ-SF was significantly lower 2 years after the procedure than before. Maximum voluntary contraction pressure (MSP), which indicates muscle strength of the external anal sphincter, increased significantly after HIFU. In patients with coexisting fecal incontinence, fecal incontinence improved in all patients, and the Wexner score was significantly lower.[ 23 ] To the best of our knowledge, this was the first study that evaluated the efficacy of HIFU therapy in patients with rectocele and cyctocele. Our results indicated that patients experienced significantly wellbeing regarding both sexual function and colorectal symptoms. A very low-risk procedure, HIFU, is considered. However, safety is a major concern for HIFU ablation of symptomatic fibroids, adenomyosis, rectocele, and cystocele because the uterus is close to structures like the urinary bladder, lumbosacral plexus, and the bowel.[ 24 ] Participants in our study did not show any significant side effects beside two patients, who suffered from first-grade burn injury.

In this study, we evaluated the efftiveness of HIFU therapy in comparison with Kegel exerecises. Our data showed good results in both sexual function and urinocolorectal symptoms, but we could not show any significant difference between Kegel excercises and HIFU. Regarding the low side effect rate and saftey of this method, we recommend further studies and clinical applicitaions. The study obtained the approval of the institutional review board at, School of Medicine, Isfahan (code: IR.MUI.MED.REC.1401.211). There are no conflicts of interest.

This clinical trial study was conducted at Shahid Beheshti hospital, Isfahan, in 2022. The inclusion criteria were women in child-bearing ages who have symptomatic (based on our questionnaire) grade 1 and 2 (based on POP-Q) rectocele and cystocele. Participants who denied informed consent and patients with history of vaginal trauma, Marfan syndrome, acute skin conditions, and HPV were excluded. Patients were randomly (using a random number generator) placed in either treatment group. HIFU device (Chongqing HIFU Medical Technology Co., Ltd., Chongqing, China) has a vaginal prop that has 1.5, 3-, and 4.5-mm cartridges. 1.5- and 3-mm cartridges are used for atrophic problems, and the 3 mm cartridge penetrates to the epidermis. The 4.5 mm cartridge penetrates the fascia. In the treatment in this study, we used 4.5 mm cartridge that penetrates to the fascia and can strengthen the pelvic muscles, and the energy produced is 1.5 joules. To shoot, the area from the end of the vagina to the front is divided into three parts, and shots are taken at intervals of 2.5 cm and less than 1 mm between each shot in each line. The frequency of the device for the 4.5 mm cartridge is 4 MHz. In another group, Kegel exercises were explained to the patients in the first session practically and the patients practiced three times a day for up to 6 months. According to UpToDate, a woman may learn to perform Kegel exercises by squeezing the muscles around her finger inside her vagina or acting as if she is sitting on a marble and must pick it up with her vagina.[ 12 ] After initiating the study, the researcher referred and visited the participants at intervals of 2 months and 6 months. Before starting the study, for baseline information, age, BMI, marital status, parity, menstrual status, marriage duration, and number of children were asked. In each session, any signs of burning injuries, pain, the pelvic floor discomfort index questionnaire (PFDI-20), and Female Sexual Function Index (FSFI) were asked and investigated in both groups. In 2000, Rosen et al .[ 13 ] created FSFI; it is a multidimensional, 19-item self-reporting measure that assesses female sexual dysfunction in six areas: lubrication, orgasm, satisfaction, arousal, desire, and pain. Each domain gets at maximum 6 points, which makes the whole questionnaire in the range of 0–36. Higher scores indicate higher sexual satisfaction. FSFI has been adapted and validated into more than 20 languages, and it is regarded as the de facto “gold standard” to assess the female sexual function.[ 14 ] The PFDI-20 has 20 items and has three scales, 1. Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), 2. Colorectal-Anal Distress Inventory 8 (CRAD-8), and 3. Urinary Distress Inventory 6 (UDI-6). Scale scores are obtained with the mean value of all of the answered items within the corresponding scale (possible value 0 to 4). The validity and reliability of both these questionnaires have been confirmed in the Iranian population.[ 15 16 ] After collecting the data, regression and repeated measure ANOVA were used for the analysis. P values less than 0.05 were considered significant. This study was approved at Isfahan University of Medical Science Ethics Committee (IR.MUI.MED.REC.1401.211) and Iranian Registry of Clinical Trials (IRCT code: IRCT20160521027998N10) and was conducted based on Helsinki declaration.