Clinical trials: Apical Prolapse
Pelvic Organ Prolapse
Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy
The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.
- Trial name
- NCT04850365
- Testing
- Hysteropexy
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Prolapse; Female, Prolapse Uterovaginal
Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair.
- Conditions
- Prolapse; Female, Prolapse Uterovaginal, Prolapse; Cervix
- Trial name
- APAS (NCT05836844)
- Testing
- The Anchorsure System®
- Where
- 4 sites in France
- Volunteers
- 120 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Prolapse Genital, Anatomical Pathological Condition
The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension
Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse.
- Trial name
- NCT03772015
- Testing
- Magnetic resonance imaging
- Where
- Turkey (Türkiye)
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
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
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Apical Prolapse
RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in…
- Trial name
- NCT04213027
- Testing
- native tissue repair procedures with conventional surgical instruments
- Where
- 5 sites in China
- Volunteers
- 320 people
- Sponsor
- Peking Union Medical College Hospital
Pelvic Organ Prolapse
Sacro-Spinous Ligaments Anterior Apical Anchoring
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
- Trial name
- NCT01842464
- Testing
- Anterior Sacro-Spinous
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Western Galilee Hospital-Nahariya
Pelvic Organ Prolapse
A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse
The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or…
- Trial name
- NCT01111409
- Testing
- VFIX Device
- Where
- 3 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
Pectopexy for Apical Prolapse Management
This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months.
- Trial name
- NCT06369857
- Testing
- Pectopexy
- Where
- Egypt
- Volunteers
- 10 people
- Sponsor
- Assiut University
Vaginal Apical Prolapse
Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter.
- Trial name
- NCT02753920
- Testing
- voiding trial, Foley catheter
- Where
- United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Sacrospinofixation, Apical Prolapse
Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery
The primary objective of this study is to demonstrate the feasibility of using a Finite Element model of pelvic organs by evaluating the concordance of pelvic organ mobility measurements performed by this mechanical model…
- Trial name
- BiomécaRichter (NCT04551859)
- Testing
- Dynamic Pelvic Floor MRI
- Volunteers
- 41 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Apical Prolapse
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
Pelvic organ prolapse, particularly apical prolapse, is a common condition among aging women, and laparoscopic sacrocolpopexy is considered the standard surgical treatment due to its high anatomical success.
- Trial name
- NCT07596498
- Testing
- Laparoscopic Pectopexy, Laparoscopic Sacrocolpopexy
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Pelvic Organ Prolapse
Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally.
- Trial name
- SSLF-CSI (NCT03782285)
- Testing
- sacrospinous Ligament Fixation
- Where
- 9 sites in China
- Volunteers
- 100 people
- Sponsor
- Peking Union Medical College Hospital
Prolapse, Vaginal Vault
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse.
- Trial name
- TVM vs LCSP (NCT04478747)
- Testing
- TVM, Colposacropexy
- Where
- Finland
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Pelvic Organ Prolapse
Smartmesh Technology in Pelvic Floor Repair Procedures
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical.
- Trial name
- Restorelle (NCT03098641)
- Testing
- pelvic organ prolapse repair
- Where
- 16 sites in France
- Volunteers
- 272 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Pelvic Organ Prolapse
The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery).
- Trial name
- E-OPTIMAL (NCT01166373)
- Testing
- Enrollment video, SSLF, ULS
- Where
- 7 sites in United States
- Volunteers
- 285 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Prolapse
Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse
Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support.
- Trial name
- NCT03609229
- Testing
- Burch, Abdominal Sacrocolpopexy
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Cystocele, Rectocele
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
- Conditions
- Cystocele, Rectocele, Enterocele
- Trial name
- NCT00833001
- Testing
- GYNECARE PROLIFT+M* Pelvic Floor Repair System
- Where
- 8 sites in Belgium, France and 2 more
- Volunteers
- 126 people
- Sponsor
- Ethicon, Inc.
Apical Prolapse, Sacrocolpopexy
Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy
The aim of the study is to evaluate the effect of cyanoacrylate adhesive in laparoscopic sacrocolpopexy, which is the gold standard treatment for apical prolapse.
- Conditions
- Apical Prolapse, Sacrocolpopexy, Glue Fixation
- Trial name
- LSCGlue (NCT06872983)
- Testing
- cyanoacrylate tissue adhesive beside sutures, Suture
- Where
- Czechia
- Volunteers
- 40 people
- Sponsor
- Brno University Hospital
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S