Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Preventive transobturator tension free vaginal tape

Study type: Interventional

Funder types: Other

Identifiers

NCT01507714

0083-11EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

control arm

No Intervention group

Description:

vaginal wall repair surgery will be done to women in this arm, with no treatment for stress incontinence

TVT-O arm

Active Comparator group

Description:

the women in this arm will have a TVT-O procedure in addition to the vaginal wall repair

Treatment:

Procedure: Preventive transobturator tension free vaginal tape