Clinical trials: Prolapse, active
Pelvic Organ Prolapse
Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques
This study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery…
- Trial name
- vnotes (NCT07082023)
- Testing
- V-NOTES Mesh-Free Sacrocolpopexy, Laparoscopic Mesh-Free Sacrocolpopexy
- Where
- Turkey (Türkiye)
- Volunteers
- 52 people
- Sponsor
- Havva Betül Bacak
Pelvic Organ Prolapse, Prolapse
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…
- Trial name
- POMEGRANATE (NCT06634459)
- Testing
- Reia System, Standard of Care Pessary
- Where
- 9 sites in United States
- Volunteers
- 218 people
- Sponsor
- Medstar Health Research Institute
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
Uterine Prolapse
Combined Effects of Pelvic Floor Retraining and Hypopressive Exercises in Uterine Prolapse Outcomes
One common pelvic floor condition, particularly in postpartum or later life, is uterine prolapse. It is caused by weak pelvic floor muscles and connective tissues and often presents with pain, urinary incontinence, and reduced…
- Trial name
- NCT07642180
- Testing
- Functional Movement Retraining + Hypopressive Exercises, Pelvic Floor Functional Movement Retraining
- Where
- Pakistan
- Volunteers
- 32 people
- Sponsor
- Riphah International University
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
This observational study aims to develop a predictive model for the occurrence of new-onset stress urinary incontinence (SUI) after pelvic organ prolapse (POP) repair surgery in women.
- Trial name
- NCT07601282
- Testing
- Telephone follow-up
- Where
- China
- Volunteers
- 382 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Pelvic Organ Prolapse
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.
- Trial name
- NCT07786337
- Testing
- Standard insufflation, Low insufflation
- Volunteers
- 164 people
- Sponsor
- University of Calgary
Pelvic Organ Prolapse, Postoperative Pain Management
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.
- Conditions
- Pelvic Organ Prolapse, Postoperative Pain Management, Gynecologic Surgeries
- Trial name
- SORE (NCT07215780)
- Testing
- Sitz Bath
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Yale University
Blepharoptosis, Device Usability
A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
To develop a feedback-enabled magnetic device for management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual field obstruction, blurred vision, foreign body sensation…
- Trial name
- NCT03812016
- Testing
- Feedback-enabled magnetic device
- Where
- 2 sites in Taiwan
- Volunteers
- 40 people
- Sponsor
- E-DA Hospital
Pelvic Organ Prolapse, Urinary Incontinence
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.
- Trial name
- NCT07692789
- Testing
- Patient reminder system
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Ohio State University
Breast Ptosis
Hybrid Autologous Breast Augmentation in Mastopexy With Internal BRA Fixation; Using Local Breast Tissues and Fat Grafting
The breast is a very important organ for women's self-esteem and is regarded as a symbol of femininity. Deviations from normal size, shape, and symmetry are interpreted as unattractive and a sign of aging.
- Trial name
- NCT07197190
- Testing
- Autologous augmentation mastopexy with subpectoral lipofilling and upper and medial pole fat grafting.
- Where
- Egypt
- Volunteers
- 28 people
- Sponsor
- Assiut University
Urinary Incontinence,Stress, Stress Urinary Incontinence
Synchronized Core-Pelvic Floor Activation in Urinary Incontinence
This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence.
- Conditions
- Urinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ, Urinary Incontinence
- Trial name
- NCT07387640
- Testing
- Conventional Pelvic Floor Muscle Training, Pelvic Floor and Core Muscle Co-activation Training
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Bezmialem Vakif University
Pelvic Organ Prolapse (POP), Postoperative Pain
Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic…
- Trial name
- vNOTES-PB (NCT07440576)
- Testing
- Bupivacaine, Normal Saline
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people
- Sponsor
- Erkan Gol
Pelvic Organ Prolapse, Stage III and IV High Grade Pelvic Organ Prolapse
Efficacy/Safety of Urogynecology Synthetic Mesh Surgery
This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or…
- Trial name
- NCT05682989
- Testing
- Urodynamic investigations before and after a mesh surgery protocol., Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol., Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair
- Where
- Taiwan
- Volunteers
- 150 people
- Sponsor
- Mackay Medical College
Rectal Prolapse, Surgery
The Nordic Rectal Prolapse Study
The goal of this observational study is to gather data about surgical procedures for rectal prolapse in adult human subjects. The main question it aims to answer is: Which procedure is best for treating external rectal prolapse?…
- Conditions
- Rectal Prolapse, Surgery, Recurrence, Quality of Life
- Trial name
- NORDIC (NCT05569980)
- Where
- Denmark
- Volunteers
- 430 people
- Sponsor
- Aarhus University Hospital
Pelvic Organ Prolapse, Genital Prolapse
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.
- Trial name
- i-StitchSSLF (NCT06805006)
- Testing
- SSLF
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women.
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Mesh Reinforcement, Vaginal Apex/Uterine Prolapse
- Trial name
- NCT07359755
- Testing
- Vaginal mesh surgery for apical prolapse, Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
- Where
- Brazil
- Volunteers
- 86 people
- Sponsor
- University of Sao Paulo General Hospital
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
Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients.
- Trial name
- REVERSE-MR (NCT03389542)
- Testing
- Surgery, Clinical interview and echocardiography
- Where
- 2 sites in France
- Volunteers
- 424 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Pelvic Floor Disorders, Pelvic Organ Prolapse
The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training
When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment.
- Conditions
- Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence
- Trial name
- NCT05778552
- Testing
- Home-based pelvic muscle training devices or traditional PFMT at hospital
- Where
- Taiwan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Prolapse Pelvic
Prophylactic Laparoscopic Suspension After McCall
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results.
- Trial name
- LAPCALL (NCT04560543)
- Testing
- McCall suture, Standard cuff closure
- Where
- Switzerland
- Volunteers
- 114 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern