Uterine 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.

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.

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.

Researchers are evaluating patient satisfaction and preparedness for urogynecology prolapse surgeries by comparing two methods of preoperative counseling: standard individual phone calls and virtual group sessions called Shared Medical Appointments (SMAs). This prospective cohort study aims to determine if virtual group counseling improves patient satisfaction and preparedness, while also assessing healthcare resource use after surgery. The study is conducted at Cleveland Clinic and focuses on patients undergoing major prolapse surgeries. Participants receive preoperative counseling either through individual nursing telehealth calls or virtual group nursing appointments. The study will recruit over 24 months, with follow-up lasting until the postoperative visit 7 to 9 weeks after surgery. Eligible surgeries include vaginal colpopexy, vaginal hysteropexy, laparoscopic sacrocolpopexy, and others, possibly combined with additional procedures. Participants complete surveys before and after surgery to measure satisfaction and preparedness. During the study, participants complete electronic surveys using validated tools like the Patient Satisfaction Questionnaire-18 (PSQ-18) and the Patient Preparedness Questionnaire (PPQ). Data collection is managed through REDCap and linked to electronic health records. Researchers will analyze satisfaction scores and healthcare use, including phone calls, unscheduled visits, and hospital readmissions, up to 12 weeks post-surgery. The study plans to enroll about 106 participants, with data securely stored and privacy protected throughout.

This research focuses on comparing early postoperative outcomes in female patients with stage 3 or 4 pelvic organ prolapse. It evaluates two surgical approaches: laparoscopic lateral suspension and V-NOTES lateral suspension using the Salman Ketenci Gencer technique. The study is observational and sponsored by Gaziosmanpasa Research and Education Hospital to understand how these methods impact pelvic organ prolapse severity. The study involves two groups of patients: those who have undergone laparoscopic lateral suspension and those treated with the V-NOTES lateral suspension using the Salman Ketenci Gencer technique. Both procedures aim to address pelvic organ prolapse, and the research compares their effectiveness by assessing postoperative improvements. Participants will be monitored for changes in pelvic organ prolapse severity using the POP-Q score at six months after surgery. The study tracks early postoperative outcomes to evaluate improvement levels. Female patients aged 18 to 75 years will be included, and the study excludes those with certain cervical pathologies, infections, or pregnancy. Participation involves follow-up assessments to measure surgical results and safety.

Apical prolapse, a form of pelvic organ prolapse, commonly affects aging women and significantly impacts quality of life. This condition involves the downward displacement of the vaginal apex, uterus, or vaginal vault and is often accompanied by urinary, bowel, and sexual problems. Researchers are comparing two laparoscopic surgical methods, pectopexy and sacrocolpopexy, to evaluate their effectiveness and learning curves for treating apical prolapse. The study compares laparoscopic pectopexy, a newer technique that uses the iliopectineal ligament for mesh fixation and offers a safer anatomical route with fewer complications, against the traditional laparoscopic sacrocolpopexy, which requires sacral dissection and carries risks such as presacral hemorrhage and nerve injury. About 15 women will undergo laparoscopic pectopexy and another 15 women will have laparoscopic sacrocolpopexy. Both groups will have their pelvic organ prolapse stages evaluated before surgery. Participants will be monitored for pain within 24 hours after surgery and the number of participants treated will be tracked over 6 months. The study involves assessments of anatomical success and safety, focusing on operative time, complications, and learning curves for each procedure. The study is sponsored by Ain Shams University and will enroll women aged 40 to 75 years with apical prolapse requiring surgical treatment.

Pelvic organ prolapse (POP) is a common condition affecting women, especially as they age and have had children, often requiring surgery. This research is evaluating and comparing two minimally invasive surgical methods for repairing POP without using synthetic mesh: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. The study aims to see if the V-NOTES technique offers similar or better surgical outcomes, safety, and patient satisfaction compared to the traditional laparoscopic approach. The two treatments being studied are mesh-free sacrocolpopexy performed through V-NOTES and through conventional laparoscopy. Both procedures are done by experienced surgeons. The study will analyze factors like operation time, complications during and after surgery, hospital stay length, pain levels, anatomical repair success, and patient satisfaction. Participants will be randomly assigned to one of these two surgical methods. Participants will be assessed before surgery and then followed up for at least six months after the procedure. Researchers will measure changes in the Pelvic Organ Prolapse Quantification (POP-Q) stage, sexual function using the PISQ-12 score, and pelvic floor distress with the PFDI-20 score from baseline to six months post-surgery. Safety, anatomical and functional outcomes, and patient satisfaction will be closely monitored throughout the study duration, which is expected to last until January 2026.

Researchers are studying women who have given birth vaginally at the University Hospitals Leuven to understand pelvic floor dysfunction (PFD) one year after delivery. The study aims to link self-reported PFD symptoms with changes in pelvic floor muscles and evidence of muscle injury using ultrasound imaging. Investigators also want to compare patient characteristics and examine how women recover and follow pelvic floor muscle training during the postpartum period. They are exploring the use of ultrasound images to develop artificial intelligence tools for automated analysis. Women will undergo pelvic floor ultrasound and complete standardized questionnaires that assess urinary, bowel, prolapse, and sexual function at three key times: upon admission to the labor suite, at the postpartum check-up, and one year after delivery. The ultrasound will document pelvic floor muscle anatomy and potential injuries. The questionnaires used include validated tools like the Pelvic Organ Prolapse Distress Index, International Consultation on Incontinence Questionnaire, and Female Sexual Function Index, among others. Participants will be followed for one year postpartum with assessments including ultrasound measurements and symptom questionnaires. Researchers will gather information from medical records about pregnancy and delivery. The main outcomes measured are urinary and anal incontinence, sexual dysfunction, and constipation at one year. Additional outcomes include detailed pelvic floor muscle injury measures and pelvic organ position. This study does not involve blinding or multiple treatment groups, focusing instead on observation and correlation of clinical and imaging findings over time.