Clinical trials: Vaginal Prolapse
Anaemia Postoperative
Clinical Utility of Postoperative Hemoglobin Testing
The purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dL at post-operative day 1
- Trial name
- NCT04170764
- Where
- United States
- Volunteers
- 664 people
- Sponsor
- TriHealth Inc.
Constipation, Prolapse, Vaginal
Effect of Preoperative Fiber on Postoperative Bowel Function
Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation.
- Trial name
- NCT04882995
- Testing
- Psyillium fiber
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Pelvic Organ Prolapse (POP)
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
- Trial name
- (A&P) (NCT01378065)
- Testing
- Restorelle Direct Fix A&P
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Nerve Block, Pain, Postoperative
Pudendal Nerve Block in Vaginal Surgery
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared…
- Conditions
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse
- Trial name
- NCT04198714
- Testing
- Pudendal block
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
Anterior Vaginal Wall Prolapse, Cystocele
Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion.
- Conditions
- Anterior Vaginal Wall Prolapse, Cystocele, Pelvic Organ Prolapse
- Trial name
- OARS (NCT01393171)
- Testing
- Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard), Anterior Colporrhaphy
- Where
- 2 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Pelvic Organ Prolapse, Perioperative/Postoperative Complications
Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures.
- Trial name
- NCT05658887
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Joseph Kowalski
Pelvic Organ Prolapse
Feasibility Study of the Reia Vaginal Pessary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ…
- Trial name
- NCT04508335
- Testing
- Reia Vaginal Pessary
- Where
- 7 sites in United States
- Volunteers
- 78 people
- Sponsor
- Reia, LLC
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
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
Cystocele, Uterine Prolapse
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.
- Conditions
- Cystocele, Uterine Prolapse, Urinary Incontinence
- Trial name
- NCT00535301
- Testing
- grafted anterior prolapse repair, sutured anterior vaginal prolapse repair
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
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
Pelvic Organ Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Prolapse
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome…
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele
- Trial name
- VAMP (NCT00475540)
- Testing
- synthetic monofilament polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
Pelvic Organ Prolapse, Urinary Incontinence
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease
- Trial name
- CLNUP (NCT04048356)
- Testing
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
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
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
Pelvic Organ Prolapse
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
- Trial name
- NCT01497171
- Testing
- Elevate Mesh, Anterior Colporrhaphy
- Where
- 6 sites in United States, Germany
- Volunteers
- 5 people
- Sponsor
- Emanuel Trabuco
Prolapse
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
- Trial name
- NCT00271102
- Testing
- anterior vaginal repair (colporrhaphy), abdominal paravaginal defect repair
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Geisinger Clinic
Pelvic Organ Prolapse
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior…
- Trial name
- NCT03436147
- Testing
- POP-Q
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Pelvic Organ Prolapse, Prolapse
Early Feasibility Study of the Reia Vaginal Pessary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse…
- Trial name
- NCT04275089
- Testing
- Reia Vaginal Pessary
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Reia, LLC
Pelvic Organ Prolapse
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision.
- Trial name
- OPUS (NCT00460434)
- Testing
- TVT
- Where
- 8 sites in United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- NICHD Pelvic Floor Disorders Network