Clinical trials: Prolapse, Vaginal Vault
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.
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, 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
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
Quality of Life, Pelvic Organ Prolapse
Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?
The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery…
- Conditions
- Quality of Life, Pelvic Organ Prolapse, Prolapses, Vaginal Vault
- Trial name
- NCT03094442
- Testing
- Dexamethasone, Normal saline
- Where
- United States
- Sponsor
- The Cleveland Clinic
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
Pelvic Organ Prolapse (POP)
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical…
- Trial name
- OPTIMAL (NCT00597935)
- Testing
- SSLF, ULS, PMT
- Where
- 9 sites in United States
- Volunteers
- 374 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Modified Extraperitoneal Uterosacral Ligament Suspension, Vault Prolapse, Vaginal
Modified Uterosacral Ligament Suspension in Vaginal Hysterectomy
Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse.
- Trial name
- NCT03832543
- Volunteers
- 40 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
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
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
Vaginal Vault Prolapse
Laparoscopic Versus Vaginal Approach Closure Complications
Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally.
- Trial name
- NCT05960292
- Testing
- Laparoscopic and Vaginal Hysterectomy
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Egymedicalpedia
Vaginal Vault Prolapse
Laparoscopic Sacrocolpopexy: Long Term Follow-up
The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.
- Trial name
- NCT01394237
- Testing
- Examination
- Where
- Switzerland
- Volunteers
- 75 people
- Sponsor
- Kantonsspital Aarau
Uterine Prolapse, Vault Prolapse, Vaginal
Pectopexy Autologous Vs Mesh
prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse
- Trial name
- NCT06524700
- Testing
- pectopexy mesh, pectopexy autologous
- Where
- 2 sites in Egypt, Saudi Arabia
- Volunteers
- 20 people
- Sponsor
- Ain Shams Maternity Hospital
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
Vaginal Vault Prolapse, Sexual Function
Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
The purpose of this study is to assess the feasibility of performing prophylactic McCall culdoplasty at the time of total laparoscopic hysterectomy.
- Trial name
- NCT01840176
- Testing
- McCall culdoplasty
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Vaginal Vault Prolapse, Pelvic Floor Prolapse
Vaginal Vault Prolapse Surgical Treatment
Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP).
- Trial name
- VVPST (NCT06792331)
- Testing
- vNOTES high uterosacral ligament suspension, Laparoscopic lateral suspension
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people
- Sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
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
Pelvic Organ Prolapse, Uterine Prolapse
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy.
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Anterior Wall; Prolapse, Vaginal, Posterior Wall; Prolapse, Vaginal
- Trial name
- NCT04009694
- Testing
- Pelvic Floor Muscle training
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Salford
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