Clinical trials: Vault Prolapse, Vaginal
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
Exair® Versus Native Tissue Repair for Prolapse
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
- Trial name
- NCT02162628
- Testing
- Exair Prolapse Repair System, Total Native Tissue Repair
- Where
- 14 sites in United States, Canada
- Volunteers
- 79 people
- Sponsor
- Coloplast A/S
Vault Prolapse, Vaginal
Comparison of PHVP of Different VTH Methods
To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using different methods of vaginal total hysterectomy (VTH).
- Trial name
- NCT03858673
- Testing
- VTH via the Tsuzi method with residual uterine ligament ligation
- Volunteers
- 213 people
- Sponsor
- National Taiwan University Hospital
Postoperative Pelvic Organ Prolapse, Benign Hysterectomy
Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital hiatus.
- Conditions
- Postoperative Pelvic Organ Prolapse, Benign Hysterectomy, Suspension
- Trial name
- NCT02859272
- Volunteers
- 11,000 people
- Sponsor
- Nykøbing Falster County Hospital
Vaginal Vault Prolapse, Pelvic Organ Prolapse
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse.
- Conditions
- Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
- Trial name
- NCT02680145
- Testing
- Preoperative Pessary Use
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Mayo Clinic
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.
Pelvic Organ Prolapse
Comparing Postoperative Pain After Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery
This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.
- Trial name
- NCT05192954
- Testing
- LigaSureTM vessel sealing device
- Where
- 2 sites in United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Marlana McDowell
Vaginal Vault Prolapse
Study of Cytrix Use in Pelvic Floor Prolapse Treatment
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
- Trial name
- NCT01244165
- Testing
- Cytrix, Other treatments for pelvic organ prolapse
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
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
Vaginal Vault Prolapse
Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair
The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of…
- Trial name
- PREFAP (NCT05628831)
- Testing
- vNOTES suspension with autologous tissue, Vaginal surgery
- Where
- Croatia
- Volunteers
- 56 people
- Sponsor
- General Hospital Zadar
Vault Prolapse, Vaginal
An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.
- Trial name
- NCT04378400
- Testing
- Sacrocolpopexy
- Where
- Belgium
- Volunteers
- 250 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Urethra Issue, Pelvic Organ Prolapse
Lessons on Urethral Lidocaine in Urodynamics
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum…
- Conditions
- Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence, Vaginal Vault Prolapse
- Trial name
- LULU (NCT04038099)
- Testing
- Water-Based Vaginal Lubricant, lidocaine topical
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Texas Southwestern Medical Center
Pelvic Organ Prolapse
Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.
The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen.
- Trial name
- LULS-1 (NCT03553511)
- Testing
- Vaginal vault suspension to the uterosacral ligaments, McCall culdoplasty
- Volunteers
- 60 people
- Sponsor
- Università degli Studi dell'Insubria
Uterovaginal Prolapse
Study of Uterine Prolapse Procedures - Randomized Trial
The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy…
- Trial name
- SUPeR (NCT01802281)
- Testing
- Uterosacral ligament suspension, Uphold® LITE
- Where
- 8 sites in United States
- Volunteers
- 183 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pelvic Organ Prolapse, Uterovaginal Prolapse
Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension
Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure.
- Conditions
- Pelvic Organ Prolapse, Uterovaginal Prolapse, Vaginal Vault Prolapse, Cystocele
- Trial name
- NCT05688059
- Testing
- Absorbable Suture and Permanent Suture
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Atlantic Health System
Vaginal Vault Prolapse
Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods
The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the…
- Trial name
- NCT02290288
- Testing
- vaginal surgery, laparoscopic surgery
- Where
- Sweden
- Volunteers
- 138 people
- Sponsor
- Sahlgrenska University Hospital
Vaginal Vault Prolapse
Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse.
- Trial name
- Lite-Y (NCT03681223)
- Testing
- Vertessa® Lite Y mesh, Restorelle® Y mesh, Laparoscopic sacrocolpopexy
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- The Cleveland Clinic
Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
- Trial name
- NCT01823055
- Testing
- Transvaginal suture capturing mesh device
- Volunteers
- 214 people
- Sponsor
- Karolinska Institutet
Uterovaginal and Vaginal Vault Prolapse
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of…
- Trial name
- NCT03487328
- Testing
- Sacrospinous-Sacrotuberous fixation
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Ain Shams University
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