Clinical trial NCT01507714: Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence
Official title: Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Preventive
tvt-o
stress incontinence
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence.

The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Detailed description: Urinary stress incontinence is defined as leakage of urine during stress (cough, lough, sneezing, coitus, heavy lifting, physical activity). Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence.

The CARE study has examined the efficacy of preventive BURCH RETROPUBIC URETHROPEXY among women who underwent abdominal sacrocolpopexy. According to this study, the BURCH procedure reduced the rate of post surgery urinary stress incontinence. The authors recommend to offer those women the preventive surgery. Those results cannot be relied on when considering vaginal wall repair by the vaginal approach.

The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Eligibility criteria: Inclusion Criteria:

* women with vaginal wall prolapse grade 2 and more
* no contraindication to vaginal wall repair or tvt-o
* No stress incontinence

Exclusion Criteria:

* urinary tract malformations
* past urinary stress incontinence surgical procedure
* UDI - question 17 or 18 - positive answer
* Occult urinary stress incontinence

Primary outcomes:
measure: Stress incontinence
timeFrame: One year post operation
Secondary outcomes:
measure: Surgical complications
timeFrame: one year
measure: post surgery urgency or urge incontinence
timeFrame: one year
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Dep of OG/GYN, Emek Medical Center
Study officials:
affiliation: HaEmek Medical Center, Afula, Israel
name: MEIRAV BRAVERMAN, MD
role: PRINCIPAL_INVESTIGATOR
References: