Clinical trials: Prolapse; Female
Prolapse, Urinary Incontinence
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the…
- Trial name
- E-CARE (NCT00099372)
- Where
- 8 sites in United States
- Volunteers
- 215 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Genital Diseases, Female, Pelvic Organ Prolapse
A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable.
- Trial name
- NCT02642835
- Testing
- vaginal wall mesh
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Medway NHS Foundation Trust
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, Cystocele
A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures.
- Conditions
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
- Trial name
- NCT02888093
- Testing
- Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Joseph Kowalski
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
Pelvic Floor Disorders
Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse
Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years.
- Trial name
- NCT02774798
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- Manchester University NHS Foundation Trust
Catheter-Associated Urinary Tract Infection
Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated…
- Trial name
- NAUTICA (NCT03287089)
- Testing
- Nitrofurantoin 100 MG
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Wake Forest University Health Sciences
Urinary Retention, Lower Urinary Tract Symptoms
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
- Conditions
- Urinary Retention, Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Trial name
- NCT03524339
- Testing
- Tamsulosin
- Where
- 2 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
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
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
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
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
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
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
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
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
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Urinary Tract Infections, Urinary Retention Postoperative
Urinary Track Infection Prevention After Urogynecological Surgery
This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with…
- Conditions
- Urinary Tract Infections, Urinary Retention Postoperative, Pelvic Organ Prolapse
- Trial name
- NCT03818321
- Testing
- Methenamine Hippurate 1 g tablet
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.
- Trial name
- NCT02155738
- Testing
- IV Acetaminophen, IV normal saline
- Where
- United States
- Volunteers
- 204 people
- Sponsor
- Halina M Zyczynski, MD
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