Clinical trials: Prolapse, Vaginal
Pelvic Organ Prolapse
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment…
- Trial name
- NCT01648751
- Testing
- Vaginal estrogen
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Pamela Moalli
Vaginal Prolapse
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result…
- Trial name
- NCT00196495
- Testing
- Polypropylene Mesh
- Volunteers
- 90 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse, Urinary Incontinence
One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review
Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division.
- Trial name
- NCT01055860
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Atlantic Health System
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Pelvic Organ Prolapse
Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh
Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure.
- Trial name
- SAME (NCT03053479)
- Testing
- Laparoscopic sacrocolpopexy, Transvaginal mesh procedure, Amreich-Richter procedure
- Where
- 7 sites in Czechia, Slovakia
- Volunteers
- 462 people
- Sponsor
- Charles University, Czech Republic
Pelvic Organ Prolapse
Perineorrhaphy Outcomes Related to Body Imagery
The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image.
- Trial name
- POETRY (NCT02548858)
- Testing
- Perineorrhaphy, No Perineorrhaphy
- Where
- 2 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
Vaginal Delivery, Pelvic Organ Prolapse
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.
- Trial name
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Urinary Incontinence, Stress, Uterine Prolapse
Colpopexy and Urinary Reduction Efforts (CARE) Protocol
Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery.
- Conditions
- Urinary Incontinence, Stress, Uterine Prolapse, Vaginal Prolapse
- Trial name
- CARE (NCT00065845)
- Testing
- Burch urethropexy at time of sacrocolpopexy
- Where
- 7 sites in United States
- Volunteers
- 322 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pelvic Organ Prolapse
Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
- Trial name
- NCT03939715
- Testing
- DermaPure®, native tissue
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Colorado Pelvic Floor Consultants
Vaginal Vault Prolapse
Laparoscopic Sacropexy With Robot-Assisted Surgical System
The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.
- Trial name
- RobPex (NCT00886223)
- Testing
- laparoscopic robot-assisted sacropexy
- Where
- Switzerland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Kantonsspital Aarau
Pelvic Organ Prolapse
Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic…
- Trial name
- RoboLaps (NCT01320215)
- Testing
- Robot-assisted promontofixation, Non-robot assisted promontofixation
- Where
- 18 sites in France
- Volunteers
- 365 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Pelvic Organ Prolapse, Vaginal Atrophy
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina).
- Trial name
- NCT00803335
- Testing
- Vaginal conjugated estrogen cream 0.5gm, Vaginal conjugated estrogen cream 1.0gm
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- TriHealth Inc.
Vaginal Prolapse
Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse
Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B).
- Trial name
- ELEPE (NCT03187574)
- Testing
- Elevate Ant™, Perigee™
- Volunteers
- 126 people
- Sponsor
- Hospices Civils de Lyon
Stress Urinary Incontinence, Vaginal Prolapse
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective.
- Trial name
- BELIEVE (NCT06754046)
- Testing
- RP-MUS, PAHG
- Where
- United States
- Volunteers
- 476 people
- Sponsor
- University Hospitals Cleveland Medical Center
Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
- Trial name
- NCT02209337
- Testing
- SRS
- Where
- 3 sites in Hungary, Israel
- Volunteers
- 20 people
- Sponsor
- Lyra Medical Ltd.
Urinary Incontinence, Stress, Mixed Incontinence
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.
- Conditions
- Urinary Incontinence, Stress, Mixed Incontinence, Vaginal Vault Prolapse
- Trial name
- NCT00223106
- Testing
- Vaginal Sling
- Where
- United States
- Volunteers
- 467 people
- Sponsor
- Medtronic - MITG
Pelvic Organ Prolapse
Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair.
- Trial name
- NCT02049996
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior…
- Trial name
- NCT03436147
- Testing
- POP-Q
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Uterine Prolapse Without Vaginal Wall Prolapse
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
- Trial name
- NCT03436979
- Testing
- NeuGuide™ System
- Where
- 15 sites in United States, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Pop Medical Solutions