Clinical trials: Prolapse, Vaginal
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, 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
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
Vaginal Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Anterior 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
- Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
- Trial name
- VAMP-A (NCT00557882)
- Testing
- synthetic polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
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
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
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
Pelvic Organ Prolapse, Urogenital Prolapse
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared…
- Conditions
- Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele
- Trial name
- IMPROVE (NCT02431897)
- Testing
- Conjugated Estrogens Cream
- Where
- 3 sites in United States
- Volunteers
- 206 people
- Sponsor
- University of Texas Southwestern Medical Center
Pelvic Organ Prolapse
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment…
- Trial name
- NCT01648751
- Testing
- Vaginal estrogen
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Pamela Moalli
Pelvic Organ Prolapse
Permanent Versus Absorbable Colpopexy Trial
Primary Aim: The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh…
- Trial name
- PACT (NCT02277925)
- Testing
- Polytetrafluoroethylene, Polydioxanone
- Where
- 5 sites in United States
- Volunteers
- 204 people
- Sponsor
- University of North Carolina, Chapel Hill
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
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
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
Vaginal Hysterectomy, Laparoscopic Supracervical Hysterectomy
Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy
The primary objective of the proposed study is to determine the difference in surgical time between minimally invasive (laparoscopic) sacrocolpopexy performed with concurrent vaginal hysterectomy versus laparoscopic supracervical…
- Trial name
- ColoplastLSC (NCT04797585)
- Testing
- Laparoscopic supracervical hysterectomy, Vaginal hysterectomy
- Where
- United States
- Volunteers
- 3 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
Pelvic Organ Prolapse
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high.
- Trial name
- NCT00372190
- Testing
- Tensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
- Where
- 13 sites in Netherlands
- Volunteers
- 194 people
- Sponsor
- Radboud University Medical Center
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
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, 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