Clinical trials: Genital Prolapse
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
Pelvic Organ Prolapse, Urinary Incontinence,Stress
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge, Bowel Dysfunction
- Trial name
- MICRO (NCT03841513)
- Testing
- Laparoscopic Burch Colposuspension
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Northwestern University
Pelvic Organ Prolapse
Smartmesh Technology in Pelvic Floor Repair Procedures
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical.
- Trial name
- Restorelle (NCT03098641)
- Testing
- pelvic organ prolapse repair
- Where
- 16 sites in France
- Volunteers
- 272 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Cholecystitis, Endometriosis
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic…
- Conditions
- Cholecystitis, Endometriosis, Bowel Obstruction, Fibroids
- Trial name
- NCT02812186
- Testing
- Deep to Moderate NMB, Moderate to Deep NMB, Rocuronium
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Stony Brook University
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, 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
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
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
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
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
Quality of Recovery, Same Day Surgery
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
- Conditions
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
- Trial name
- NCT03338400
- Testing
- Dexamethasone, Normal saline
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- The Cleveland Clinic
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, 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, 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
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