Clinical Research Directory

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence

Nowadays the clinical significance of an occult stress urinary incontinence and its optimal treatment is not known.Regarding treatment, there are 2 main approaches : either the systematic preventive treatment of the occult stress urinary incontinence by means of a tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of prolapse in the first place and treatment of stress incontinence in a second time when and if it appears.This study is expected to provide objective evidence concerning the efficacy and security of TOT implantation for the prevention treatment of occult stress urinary incontinence in women with pelvic organ prolapse and occult urinary incontinence.The perspective is to improve the management of these patients by providing evidence based recommendation for their treatment.

SCP vs HUSLS for Pelvic Organ Prolapse Repair

The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.

Vaginal Microbiota as a Decisive Factor in Vaginal Prosthetic Surgery

Retrospective analysis of vaginal microbiota in the post-operative course of patient operated for genital prolapse with vaginal mesh with or without mesh related complication

Physical Therapy Intervention for Pelvic Organ Prolapses

Pelvic floor muscle training (PFMT) and pessaries are first-line non-surgical conservative treatments for pelvic organ prolapse (POP). High-Intensity Focused Electromagnetic Field (HIFEM) is a noninvasive and painless device, designed to promote muscle strengthening and growth and has become a popular treatment option for urinary incontinence in the field of gynecology. However, HIFEM has not yet been rigorously compared to traditional physical therapy for POP. The objectives of this pilot study are to explore clinical effects of HIFEM on POP symptoms; to compare the effectiveness of HIFEM versus PFMT with biofeedback, and usual care on patient-centered outcomes; and to explore the acceptability of the interventions. This is a prospective, single-center randomized controlled trial with a nested qualitative interview study. Twenty-one women with POP, aged \>20 years, will be recruited and randomly allocated to three groups, 'HIFEM' group, 'Biofeedback' group, and 'Usual care' group.The 'HIFEM' group will be asked to sit straight in the center of an electromagnetic chair and remained fully clothed for 28 minutes. The 'Biofeedback' group will receive PFMT with biofeedback and/or electrostimulation. Both 'HIFEM' and 'Biofeedback' groups will receive the interventions twice a week for 8 weeks. Participants allocated to the 'Usual care' group will receive the lifestyle advice leaflet only. All participants will be assessed for pelvic floor muscle function, symptom severity of POP, occurrence and distress related to pelvic floor dysfunction, and impact of pelvic floor dysfunction at baseline and immediately post-intervention.

Vaginal Vault Native Tissue Suspension

Vaginal vault suspension at time of abdominal hysterectomy using Mackenrodt and uterosacral ligaments.

Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

This prospective multicenter single-arm study evaluates the effectiveness and safety of a novel volumetric cross-shaped vaginal pessary in women with pelvic organ prolapse who had prior experience using a traditional vaginal pessary. Each participant serves as her own control by comparing outcomes after fitting of the cross-shaped pessary with documented baseline outcomes during prior traditional pessary use.

Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial

This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative vaginal surgery technique for correction of pelvic organ prolapse (POP) in women. Vaginal surgery is preferred as minimally invasive, however the investigators do not know if materials such as synthetic polypropylene mesh improve success, durability and cost-effectiveness long-term. The investigators principal goal is to compare the experimental bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M) to the current standard of sacrospinous ligament suspension with synthetic sutures (SSLS) over a timeline of 2 years. Patients and evaluators will be blind to technique.

Accelerometer Measured Early Recovery After Prolapse Surgery

The AccelERate study will evaluate the physical recovery of patients who have undergone Pelvic Organ Prolapse (POP) surgery. This will be evaluated via a self-reported recovery questionnaire completed daily. Participants will wear an accelerometer device on their non-dominant wrist and be given either routine or exercise-focused postoperative instructions. The primary outcome will be a comparison of the number of days needed to reach self-reported "mostly recovered" status between randomly assigned instruction groups.

Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study

This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.