Clinical trials: Pelvic Prolapse
Pelvic Organ Prolapse
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
The aim of this study is to further evaluate this minimally invasive SSLF technique with respect to safety, clinical effectiveness, and patient satisfaction.
- Trial name
- NCT03991455
- Testing
- Apyx device
- Where
- Israel
- Volunteers
- 17 people
- Sponsor
- Escala Medical LTD
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
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
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical
Hemorrhoids, Rectal Mucosa Prolapse
Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
The aim of this study is to define the significance of the distance of the staple line to the dentate line of the anal canal in the efficacy of the Longo's intervention.
- Trial name
- NCT03383926
- Testing
- 4.5cm suture, 6cm suture
- Where
- Spain
- Volunteers
- 119 people
- Sponsor
- Hospital de Mataró
Rectal Prolapse
Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
Incarceration and necrosis of rectal prolapse is rare and often requires urgent management. Perineal rectosigmoidectomy (Altemeir procedure) is a reasonable technique for this condition.
- Trial name
- NCT03643393
- Testing
- perineal rectosigmoidectomy
- Volunteers
- 2 people
- Sponsor
- Viet Duc University Hospital
Pelvic Organ Prolapse
Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh
Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude.
- Trial name
- NCT00402844
- Testing
- Transvaginal mesh- PROLIFT®-system
- Where
- 26 sites in Denmark, Finland and 2 more
- Volunteers
- 250 people
- Sponsor
- Karolinska Institutet
Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse (POP)
Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery
This is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy…
- Trial name
- PINPOPS (NCT07006129)
- Testing
- Perineorrhaphy, No perineorrhaphy
- Where
- Sweden
- Volunteers
- 40,646 people
- Sponsor
- Lund University
Pelvic Organ Prolapse
Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair
This study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for pelvic organ prolapse (POP) on pelvic anatomy using dynamic magnetic resonance imaging (MRI) of the pelvis.
- Trial name
- NCT03315715
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.
This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently…
- Trial name
- NCT03421067
- Where
- United States
- Volunteers
- 3,458 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Bowel Symptoms
Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.
- Trial name
- NCT02731391
- Testing
- Pelvic floor reconstruction（with or without mesh）
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Peking University People's Hospital
Pelvic Organ Prolapse, Rectal Prolapse
Materiovigilance After Urinary Incontinence or Prolapse Surgery
Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery…
- Conditions
- Pelvic Organ Prolapse, Rectal Prolapse, Urinary Stress Incontinence
- Trial name
- VIGI-MESH (NCT03052985)
- Testing
- urinary incontinence, pelvic organ or rectal prolapse surgery
- Where
- 31 sites in France
- Volunteers
- 19,000 people
- Sponsor
- Poitiers University Hospital
Uterine Prolapse, Urinary Incontinence
Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse.
- Conditions
- Uterine Prolapse, Urinary Incontinence, Fecal Incontinence
- Trial name
- uropro (NCT01766193)
- Testing
- vaginal delivery, forceps extraction, vacuum extraction
- Where
- Norway
- Volunteers
- 1,641 people
- Sponsor
- Norwegian University of Science and Technology
Vaginal Prolapse
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse.
- Trial name
- NCT04078802
- Testing
- VNOTES/VH
- Volunteers
- 60 people
- Sponsor
- Rambam Health Care Campus
Rectal Prolapse
Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy…
- Trial name
- Bergamaschi (NCT01022034)
- Testing
- sacral rectopexy with sutures or meshes, full rectal mobilization from the sacrum without sacral rectopexy
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Societa Italiana di Chirurgia ColoRettale
Pelvic Organ Prolapse, Hysterectomy
Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy
The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. The investigators are doing this research study to understand the relationship between microbes (the microbiome)…
- Conditions
- Pelvic Organ Prolapse, Hysterectomy, Urinary Tract Infection
- Trial name
- NCT02751073
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Mayo Clinic
Pelvic Organ Prolapse
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP. (*TRADEMARK)
- Trial name
- NCT00521066
- Testing
- GYNECARE PROSIMA* Pelvic Floor Repair System
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
Pelvic Floor Disorders
Multicenter Study on the Correction of Prolapse Via Laparoscopy
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional…
- Trial name
- NCT06815731
- Testing
- lateral laparoscopic suspension (LLS), Sacropexy without posterior mesh fixation on the puborrectalis muscle
- Where
- Spain
- Volunteers
- 181 people
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sexuality, Pelvic Organ Prolapse
Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality
The primary objective of this study is the psychometric validation of two questionnaires (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on female sexual function (FSFI).
- Conditions
- Sexuality, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence
- Trial name
- NCT01632839
- Where
- 14 sites in France
- Volunteers
- 298 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Vaginal Prasterone Versus Estriol in Women With Pelvic Floor Disorders
This prospective, non-randomized comparative study evaluated the effects of short-term vaginal treatment with prasterone or estriol in women with pelvic floor disorders who were awaiting urogynecological surgery.
- Trial name
- NCT07854873
- Testing
- Prasterone (DHEA), Estriol
- Where
- Poland
- Volunteers
- 74 people
- Sponsor
- Poznan University of Medical Sciences
Visceral Prolapse
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment.
- Trial name
- ASPIRe (NCT02676973)
- Testing
- Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair, Uphold™ LITE
- Where
- 10 sites in United States
- Volunteers
- 360 people
- Sponsor
- NICHD Pelvic Floor Disorders Network