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

NCT01507714 | Unknown DMC

• 1 other identifier: 0083-11EMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Preventive; tvt-o; stress incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Surgical complications

  one year

• post surgery urgency or urge incontinence

  one year

Study Arms (2)

control arm

NO INTERVENTION

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

TVT-O arm

ACTIVE COMPARATOR

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

Procedure: Preventive transobturator tension free vaginal tape

Interventions

Preventive transobturator tension free vaginal tape PROCEDURE

during the vaginal wall repair surgery, a TVT-O procedure will be done

Also known as: GYNECARE TVT™ Obturator System

TVT-O arm

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Dep of OG/GYN, Emek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• MEIRAV BRAVERMAN, MD

  HaEmek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

IL (1)