Pelvic Organ Prolapse

Researchers are collecting information from women who have pelvic organ prolapse (POP) and are treated with trans-vaginal mesh surgery. This hospital-based, multi-center study aims to observe and record postoperative complications, especially mesh exposure or erosion, using an international classification system. The study includes patients from 41 centers across China and will track outcomes over 12 and 36 months after surgery to understand current practices and complication rates in this population. Participants receive pelvic floor reconstructive surgery using either commercial mesh kits or self-cut synthesized mesh through the vagina. The study observes these patients without altering their treatment choice, focusing on how the surgery is performed and its results. Follow-up assessments occur at various points up to three years after surgery, including evaluations at 6 weeks, 3 months, 1 year, and annually to monitor anatomical cure rates and complications. During the study, participants will complete questionnaires about their pelvic health and sexual function using tools like POP-Q, PGI-I, PFDI-20, PFIQ-7, and PISQ-12 at scheduled visits. Researchers will review complication rates at 12 and 36 months while examining changes in symptoms and quality of life. Participants are expected to provide contact information for follow-up and complete online surveys through WeChat. The total follow-up lasts for 36 months after surgery, with ongoing data collection to better understand long-term outcomes and management of trans-vaginal mesh procedures.

Prostate cancer is a common malignant tumor in men, with laparoscopic radical prostatectomy (LRP) being a primary treatment for early stages. Postoperative urinary incontinence remains a major complication affecting quality of life. This trial evaluates a new bladder neck and urethral reconstruction technique during LRP to improve early urinary control, comparing it with conventional methods through a randomized controlled design involving four patient groups. The study includes four groups receiving different surgical procedures: posterior wall reconstruction using an "inverted tennis racket" method, posterior reconstruction combined with anterior suspension, a sham surgery group, and an anterior suspension group alone. All groups undergo LRP via an extraperitoneal approach. The new technique involves reconstructing the bladder neck to narrow its opening and lengthen the posterior bladder wall, with some groups also receiving suturing of the anterior bladder wall to support the urethra. Participants are followed after surgery to assess urinary control immediately after catheter removal and at 1, 3, 6, and 12 months post-operation. Assessments use the International Consultation on Incontinence Questionnaire-Short Form, daily urine pad usage, and 24-hour pad weight. The primary outcome is the rate of continence at these time points. Safety and quality of life effects are also monitored throughout the study, which lasts at least one year post-surgery.

Researchers are studying surgical preparedness in Latinas undergoing urogynecologic surgery to develop and test a telehealth intervention called TIPPS-Latina. The study aims to understand factors affecting preparedness, design a patient-centered intervention using Human Centered Design and Dissemination & Implementation methods, and pilot test the intervention for feasibility and implementation. This project involves a participatory action framework guiding all study phases. Participants scheduled for urogynecologic surgery will be randomly assigned to receive either routine preoperative counseling alone or routine counseling plus the TIPPS-Latina telehealth intervention. The intervention development follows a three-phase Discover, Design/Build, and Test framework, using mixed methods to refine and evaluate the telehealth support tailored for Latinas. The study includes community patient partners to guide research and intervention design. Participants will complete assessments including the Surgical Preparedness Assessment, health literacy, self-efficacy, trust in provider, decisional conflict, anxiety/depression, and satisfaction with healthcare services. These are measured at preoperative visits, on the day of surgery before the procedure, and 6-8 weeks postoperatively. The study evaluates the intervention's feasibility, acceptability, and appropriateness during preoperative holding on surgery day, with monitoring of implementation outcomes and patient-reported measures over the course of the trial.

Researchers are evaluating the physical recovery of women undergoing minimally invasive surgery for Pelvic Organ Prolapse (POP). This study compares recovery times between women who receive routine postoperative instructions and those who follow a prescribed exercise program. The goal is to see if early exercise after surgery leads to faster recovery without negatively affecting pelvic floor health or surgical outcomes. Participants will be randomly assigned to either a control group receiving standard postoperative advice or an intervention group instructed to perform 30 minutes of medium-intensity exercise starting on postoperative day 3, at least five times weekly for six weeks. All participants will wear an accelerometer on their non-dominant wrist to objectively measure physical activity before and after surgery. Recovery progress will be tracked daily through a mobile app until participants report feeling mostly recovered. During the study, participants will complete physical tests and questionnaires at baseline, 2, 6, and 12 weeks post-surgery, with a final assessment one year after surgery. Researchers will monitor recovery status, pelvic floor symptoms, activity adherence, and anatomical outcomes. Data collection includes self-reported recovery, accelerometer readings, physical performance tests, and clinical evaluations, with safety and adverse events recorded throughout the study period.

Pelvic organ prolapse is a common condition affecting 30 to 40% of women, with about 12% experiencing symptoms that impact their psychological, physical, and social well-being. Laparoscopic sacrocolpopexy is considered the surgical gold standard treatment, aiming to support the vaginal vault using a prosthesis. The procedure shows a high patient satisfaction rate of 94% and a low overall complication rate of 11%. This study focuses on evaluating the success of outpatient laparoscopic sacrocolpopexy, with or without robotic assistance, in women with symptomatic pelvic organ prolapse. The study is a national multicenter prospective trial including 80 female patients aged 40 to 80 years with significant prolapse. Patients will undergo outpatient laparoscopic sacrocolpopexy, either with or without robotic assistance. Outpatient success is defined by no need for inpatient admission within 24 hours after surgery, based on specific clinical criteria such as CHUNG score, absence of perioperative complications, and no urinary retention requiring catheter reinsertion. The surgical procedure remains the same as in hospital, but patients will return home the same day if their condition allows. Participants will be followed for one month, with a postoperative visit at 30 days to assess the effectiveness of the surgery using standard measures like POP-Q and several quality-of-life questionnaires. Researchers will monitor the success rate of outpatient treatment and the percentage of failures within the 24-hour post-surgery period. This preliminary study aims to establish a reference for successful outpatient sacrocolpopexy, potentially guiding larger trials comparing outpatient and inpatient treatments for pelvic organ prolapse.

Researchers are conducting an observational study to improve understanding of the menstrual cycle and various gynecologic health conditions such as polycystic ovary syndrome (PCOS), infertility, and breast cancer. This study focuses on reproductive health and menstrual patterns in women and aims to gather long-term data to describe these aspects epidemiologically. The study is hosted on the Apple Research app, which participants can use to find, enroll in, and take part in this research. It collects data related to menstrual cycle patterns and the prevalence of gynecologic health conditions over a period of up to 10 years. Participants will engage through the app, providing information about their menstrual cycles and health conditions. The study tracks menstrual cycle patterns and collects epidemiologic data over time, also determining the prevalence of related health issues. This observational approach allows long-term monitoring without administering treatments. The study is expected to continue through November 2029.

Researchers are comparing two surgical treatments for stress urinary incontinence (SUI) in women undergoing pelvic organ prolapse repair. The study aims to determine which procedure, retropubic midurethral sling (RP-MUS) or urethral bulking with polyacrylamide hydrogel (PAHG), leads to better patient-reported outcomes and fewer complications over 24 months. This is a double-blinded, randomized trial designed to evaluate patient satisfaction and long-term effects of these treatments. Participants will be randomly assigned to receive either the RP-MUS, a minimally invasive tape placement surgery through the retropubic space, or the PAHG injection, which involves injecting a bulking agent into the urethra along with sham incisions to maintain blinding. Pelvic organ prolapse will be repaired using native tissue only, and patients will remain blinded to treatment unless complications arise. The study includes six visits over two years, with symptom questionnaires and occasional interviews for selected participants. During the study, participants will complete validated symptom questionnaires before surgery and at 1, 6, 12, and 24 months afterward to assess urinary symptoms, sexual function, and quality of life. Researchers will monitor retreatment rates, pelvic organ prolapse recurrence, and surgical complications. Some participants will take part in interviews at multiple timepoints to share their experiences. The trial will collect data continuously for two years to evaluate both short- and long-term outcomes and patient satisfaction.

This research aims to compare the effectiveness of the OviTex 1S permanent mesh with the standard polypropylene mesh in minimally invasive pelvic floor surgeries for patients with pelvic organ prolapse. It addresses the ongoing debate over synthetic versus biological mesh use, especially following FDA restrictions on transvaginal mesh and concerns about complications such as fistulation and mesh exposure. The study is a prospective, multicenter trial focusing on robotic ventral mesh rectopexy (VMR) and sacrocolporectopexy (SCR) or cervicopexy. Participants will undergo robotic-assisted surgery using either the standard polypropylene mesh or the OviTex 1S mesh, which combines sheep extracellular matrix with polypropylene fibers to potentially offer strength with reduced inflammatory response. All surgeries use the da Vinci Si-HD robotic system. The study includes several phases assessing feasibility, safety, and efficacy, with a focus on complications within 90 days post-surgery and longer-term outcomes over 24 months. The trial is a partially randomized patient preference study. During the study, participants will be monitored through questionnaires assessing pelvic floor distress, constipation, incontinence, sexual function, and quality of life before and up to 24 months after surgery. Researchers will also track complications, recurrence rates of prolapse, hospital stay length, and additional medical visits. This detailed follow-up aims to capture both functional outcomes and safety data to evaluate the potential of OviTex as an alternative mesh for pelvic floor repair.

This research aims to evaluate the effects of empty versus full bladder protocols during radiation therapy for common pelvic cancers affecting the genitourinary, gynecological, and gastrointestinal systems. Radiation therapy is important in treating these malignancies, but the typical full bladder approach can cause variations in bladder size, potentially altering radiation dose distribution and side effects. This study addresses the lack of prospective data comparing these two bladder preparation methods. Participants are randomly assigned to either a full bladder or empty bladder protocol for their CT simulation and subsequent radiation treatments. The full bladder protocol involves patients maintaining a full bladder as traditionally recommended, while the empty bladder protocol involves patients having an empty bladder during treatment. Both protocols are evaluated to understand their impact on radiation delivery and treatment outcomes. During the study, participants will undergo CT simulations and receive radiation therapy according to their assigned bladder protocol. Researchers will assess acute toxicity within three months after radiation treatment, focusing on side effects related to radiation exposure. Participants will be monitored throughout the treatment period to track any changes or complications. The study duration and follow-up extend at least three months post-radiation to evaluate these outcomes effectively.

Researchers are evaluating whether precisely targeted injections of botulinum neurotoxin (commonly known as Botox) provide better relief for pelvic floor muscle tightness and pain compared to the standard injection method. This study focuses on women with pelvic floor disorders and aims to understand both the benefits and potential side effects of using targeted Botox injections. It is a Phase 1 randomized clinical trial sponsored by the University of Miami. Participants will be randomly assigned to one of two groups: one group will receive injections using a standard template followed by high-density surface electromyography (HD-sEMG) guided injections, while the other group will receive the HD-sEMG guided injections first followed by the standard template. Each participant will receive approximately 200 units of botulinum neurotoxin injected into the pelvic floor muscles twice during the study. The HD-sEMG device, which helps guide the injections, will be used five times and each use lasts about ten minutes. Participants will remain in the study for up to 15 months. During the study, researchers will assess muscle tightness using HD-sEMG one month after injection and track changes in pelvic pain and symptoms through self-reported questionnaires at baseline and one month post-injection. The primary outcome is the hypertonic index of the pelvic muscles measured by HD-sEMG. Safety and symptom changes will also be monitored. Participants will be closely followed to evaluate effects and any side effects over the course of the trial.