Clinical Research Directory

Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy

Advice on how long to limit physical activity after pelvic floor surgery ranges from 2 to 12 weeks and rests mainly on local tradition rather than data. This prospective observational study follows women undergoing a retropubic midurethral sling (TVT) for stress urinary incontinence or a laparoscopic sacrocolpopexy for pelvic organ prolapse at a single centre in Poland. For 6 weeks after surgery, participants keep a weekly diary of ten everyday activities, pain, and the reasons for not resuming each activity, and they complete validated questionnaires up to 6 months. The study does not change any aspect of treatment. Its main aim is to estimate the time to return to the pre-operative level of physical activity in each cohort.

i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.

Post-market Clinical Follow-up of the SRS Implant

National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.

Pelvic organ prolapse is an increasingly common functional disorder which affects approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the surgical "gold standard" for the treatment of this functional disorder. It aims to suspend the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94% with low overall complication rate, evaluated at 11%. Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the future due to increasing life expectancy. 13% of women will undergo this type of procedure. The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be the benchmark for surgical activity in all eligible patients, and has expressed the need for recommendations and tools for supporting its development. The rate of outpatient surgery for prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse) in 2015 was 3.43 days. These procedures have been the subject of publications concerning outpatient care and involving low numbers of patients, with the exception of the publication by Sinhal which involved 111 patients.

CREDE Study: Intraoperative Crede Manoeuver Compared to Preoperative Prolapse Reduction Stress Test to Predict Postoperative de Novo Stress Urinary Incontinence (PONSUI) at the Time of Pelvic Organ Prolapse (POP) Surgery

The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.

Pelvic Floor Muscle Training During Pregnancy

The project seeks to investigate effectiveness of PFMT during pregnancy.

Effects of a Follow-up Based Nursing Care Protocol on Pelvic Organ Prolapse

The goal of this clinical trial is to evaluate the effects of a follow-up-based nursing care protocol-implemented during the perioperative and post-discharge home care processes-on pelvic organ prolapse symptoms, quality of life, and sexual functions in women who underwent surgery for pelvic organ prolapse. The main questions it aims to answer are: Is the follow-up-based nursing care protocol effective in reducing pelvic organ prolapse symptoms and improving quality of life and sexual functions? What are the comparative outcomes between the intervention group (receiving video-supported education and structured follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months) and the control group (receiving routine perioperative nursing care)? Researchers will compare the intervention and control groups to determine the impact of the nursing care protocol on patients' recovery, quality of life, and symptom scores over a 6-month period.

Vaginal Orthosis Use After Vaginal Reconstructive Surgery

A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.

Pessary Experience Study

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.

Improving Uroflowmetry Interpretability: Evaluating the Impact of Patient Reminder Systems

The purpose of this study is to evaluate the impact of pre-procedure patient reminder systems on patient satisfaction, preparedness, and anxiety among patients undergoing urodynamics studies. The rate of successful procedure completion will be compared between a prospective intervention group and a historical control group to determine whether the intervention improves procedural success and healthcare delivery.

Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP

The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture. Subsequently, a multicentre, randomized intervention study is planned to confirm the results and evaluate the long-term outcomes.

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

SORE Study: Sitz Baths After Urogynecologic Reconstruction

The purpose of this study is to evaluate the utility of postoperative sitz baths in patient pain perception and recovery following surgical repair of prolapse. The SORE Study is a prospective, randomized controlled trial that aims to compare postoperative pain intensity one week after native tissue repair of pelvic organ prolapse for patients undergoing a sitz bath regimen versus usual care. Findings from this study may contribute to more robust, multimodal postoperative pain management plans if proven efficacious or, alternatively, reduce plastic medical waste and simplify postoperative pain plans if found to be ineffective.

Physical Therapy on Pelvic Organ Prolapse

OBJECTIVE: To evaluate the effectiveness of an individualized pelvic floor physiotherapy programme combined with lifestyle education compared with lifestyle education alone in women with stage I or II pelvic organ prolapse (POP). DESIGN: Randomized controlled clinical trial with blinded outcome assessment. A total of 120 women were randomly allocated to an experimental group receiving an individualized pelvic floor physiotherapy programme plus lifestyle education or to a control group receiving lifestyle education alone. Assessments were performed at baseline, immediately after the intervention, and at 3, 6, and 12 months. PRIMARY OUTCOMES: Pelvic floor symptoms and their impact on daily life, assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7). SECONDARY OUTCOMES: Anatomical pelvic organ prolapse stage and pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale and by perineal manometry. DATA ANALYSIS: Treatment effectiveness will be evaluated by comparing changes over time between groups throughout the 12-month follow-up.

EASE: The Materna Prep Pivotal Study

This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.

Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

The goal of this observational study is to learn about the therapeutic effects of different pelvic floor rehabilitation treatments, including pelvic floor muscle training , pelvic floor biofeedback electrical stimulation, and magnetic stimulation, in a population of Chinese patients with female pelvic floor dysfunction disorders. The study aims to find out the individualised pelvic floor rehabilitation treatment plan suitable for the Chinese population. The main question it aims to answer is: 1. Do patients with reduced pelvic floor muscle strength after childbirth, or patients with mild to moderate pelvic organ prolapse and symptomatic pelvic organ prolapse benefit from pelvic floor rehabilitation? 2. Is the combination of biofeedback electrical stimulation plus pelvic floor magnetic stimulation superior to single electrical stimulation, magnetic stimulation or pelvic floor muscle training? 3. Which pelvic floor rehabilitation therapy is most suitable for Chinese patients with female pelvic floor dysfunction? 4. What factors are early predictors of developing female pelvic floor dysfunction? And what factors can predict the prognostic status of patients treated with pelvic floor rehabilitation? Participants in the multicenter will be treated with different rehabilitation therapies, during which the researchers will collect clinical symptoms using the PFDI20 questionnaire, and POP-Q scores, pelvic floor muscle strength, and electromyography results from participants before, at the end of, and 3 months and 1 year after the end of treatment.

How Low Can You Go

This is a randomized controlled trial to determine if lower intraabdominal operating pressure reduces post-operative pain in patients scheduled to undergo laparoscopic uterosacral suspension surgery of the uterus or vaginal vault.

Efficacy of Platelet Rich Plasma on Pelvic Floor Muscle Strength and Recurrence Rate in Pelvic Organ Prolapse Surgery

Pelvic organ prolapse (POP) is a common pelvic floor disorder associated with impaired quality of life and considerable postoperative recurrence following native tissue repair. Platelet-rich plasma (PRP) has emerged as a regenerative adjunct to improve tissue healing and surgical outcomes. Objective: To evaluate the effect of adjuvant PRP on pelvic floor muscle A single-blind randomized controlled trial was conducted involving 40 women with stage II or higher POP who were randomly assigned to surgery with adjuvant PRP (n=20) or surgery alone (n=20). Pelvic floor muscle strength was assessed by perineometry, while anatomical outcomes were evaluated using the Pelvic Organ Prolapse Quantification (POP-Q) system 8 weeks postoperatively.

Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

Early Safety of Resection Rectopexy and Sacrocolpopexy

Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life and conservative treatment options are limited. In cases surgery is required the interventions are characterized by individual approaches. Laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) was established in an interdisciplinary setting.

Centered Surgery - Preoperative Counseling and Patient Satisfaction

This study is a prospective cohort study which aims to assess patient satisfaction and preparedness for surgery through two methods of preoperative counseling: standard individual phone calls versus virtual group sessions called Shared Medical Appointments (SMAs). The study will focus on patients undergoing urogynecology prolapse surgeries at Cleveland Clinic. Researchers hypothesize that virtual group counseling will improve patient satisfaction and preparedness compared to individual phone calls. Additionally, the study will evaluate healthcare resource utilization as a secondary outcome. Participants will complete surveys before and after surgery to measure satisfaction and preparedness using validated tools. The study will enroll patients aged 18 and older who can provide informed consent and are scheduled for specific prolapse surgeries. Findings may help improve preoperative counseling practices and enhance patient-centered care.

POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment

This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 200 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events. Specific Aims Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.

Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery

The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.