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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01507714
• Other study ID #: 0083-11EMC
• Status: Not yet recruiting
• Phase: N/A
• First received: January 2, 2012
• Last updated: January 8, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2012
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Urinary Incontinence, Stress

Intervention

Procedure:
• Preventive transobturator tension free vaginal tape
during the vaginal wall repair surgery, a TVT-O procedure will be done

Locations

Country	Name	City	State
Israel	Dep of OG/GYN, Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress incontinence	The women will be classified as continent or not continent according to: the Pelvic Floor Distress Inventory; stress test; need to other treatment for stress incontinence	One year post operation	No
Secondary	Surgical complications	Surgical complication	one year	No
Secondary	post surgery urgency or urge incontinence	urgency or urge incontinence	one year	No