Uterine Prolapse

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, DesignBuild, 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, anxietydepression, 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 interventions 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.

This research aims to evaluate patient satisfaction and preparedness for urogynecology prolapse surgeries based on the type of preoperative counseling received. It compares standard individual phone calls to virtual group sessions called Shared Medical Appointments SMAs. The study focuses on adult patients scheduled for specific prolapse surgeries and also looks at healthcare resource use after surgery to help improve patient-centered preoperative care. Participants receive preoperative counseling through either individual telehealth nursing appointments or virtual shared nursing group sessions. Surveys measuring satisfaction and preparedness are completed before and after surgery using validated questionnaires. The study runs from June 2026 to December 2027, with follow-up lasting up to the postoperative appointment, typically 7 to 9 weeks after surgery. Participants are screened at their initial surgical consultation and complete electronic surveys via REDCap before and after surgery. Data from electronic health records and surveys are securely collected and analyzed. The main measurement is patient satisfaction assessed by the PSQ-18 questionnaire during preoperative and postoperative visits. Healthcare resource use is tracked for up to 12 weeks after surgery. The study aims to enroll about 106 patients and emphasizes data privacy and confidentiality throughout participation.

Uterine prolapse is a common pelvic floor condition that mainly affects women postpartum or later in life due to weakened pelvic muscles and connective tissues. It often causes pain, urinary incontinence, and lowers quality of life. This clinical trial explores the combined effects of Hypopressive Exercises HE and Pelvic Floor Functional Movement Retraining PFFMR compared to single interventions in women with stage I-II uterine prolapse aged 30 to 60 years. Participants will be randomly assigned to two groups. One group will receive both PF-FMR and HE through supervised sessions three times a week for 8 weeks, focusing on posture, breathing, and functional movements. The other group will receive PF-FMR alone with the same schedule, including home exercises and adherence tracking. HE involves breathing techniques to reduce abdominal pressure, while PF-FMR works on pelvic muscle control and stability through integrated movements. During the study, participants will be assessed at the start and after 8 weeks using tools like the Pelvic Floor Bother Questionnaire for symptoms, the Numeric Pain Rating Scale for pain, and the Prolapse Quality of Life Questionnaire. Data will be analyzed to see changes in pain, urogynecological symptoms, and quality of life. The trial is conducted under medical supervision at Ganga Ram Hospital, Lahore, and aims to provide detailed insight into these interventions combined effects.

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 evaluating two measures to improve the surgical field during vaginal natural orifice transluminal endoscopic surgery vNOTES hysterectomy, a procedure performed entirely through the vagina without abdominal incisions. The study is a randomized trial using a 2x2 factorial design to test whether a preoperative low-residue diet for three days, deeper intra-operative muscle relaxation deep neuromuscular blockade, or their combination improve visualization by reducing bowel interference. This trial focuses on benign gynecological conditions such as uterine leiomyoma, abnormal bleeding, uterine prolapse, and adenomyosis. Participants are assigned equally to one of four groups no diet with standard relaxation, diet with standard relaxation, no diet with deep relaxation, or diet with deep relaxation the bundle. Deep neuromuscular blockade is maintained by continuous rocuronium infusion, while standard relaxation uses intermittent rocuronium boluses both groups receive reversal with sugammadex before extubation. The low-residue diet restricts fiber intake to less than 10 grams daily for three days before surgery, avoiding raw fruits, vegetables, legumes, nuts, and seeds but allowing refined grains and cooked foods. No mechanical bowel preparation is used in any group. During surgery, the surgical field is assessed objectively by lowering carbon dioxide insufflation pressure stepwise from 12 to 6 mmHg while blinded assessors score video clips for field adequacy. Researchers measure the lowest pressure at which the surgical field remains adequate as the primary outcome. Secondary measures include continuous field scores, need for additional instruments, postoperative nausea and vomiting, operative time, blood loss, and complications. Participants are monitored during surgery and up to 24 hours postoperatively, with full neuromuscular recovery confirmed before extubation.

Researchers are evaluating the use of a Shore durometer, a device that measures hardness, to assess uterine tone in women undergoing cesarean delivery. The study aims to find a more accurate and precise way to measure uterine tone, which is currently assessed using a qualitative 0-10 numeric scale. This device has shown promising results in previous studies but has not yet been validated specifically during cesarean delivery. In this single-arm trial, the Shore durometer will be used to measure the hardness of the uterus after the placenta is delivered during cesarean section. Measurements will be taken at the lower uterine segment and fundus immediately after placental delivery, and then again at 3 and 10 minutes post-delivery. The study will compare these durometer readings with the traditional 0-10 uterine tone score to evaluate correlation and feasibility. Participants will undergo scheduled cesarean delivery at the University of Chicago Family Birth Center. The durometer measurements will be taken within 10 minutes after placental delivery to assess feasibility. Researchers will monitor the durometer readings at specified time points and compare them with clinical uterine tone scores. The total participation involves the cesarean procedure and the immediate post-delivery measurement period, focusing on the devices performance and reliability.