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

This study is not yet open for participant recruitment.
Verified January 2012 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01507714
First received: January 2, 2012
Last updated: January 8, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
 Procedure: Preventive transobturator tension free vaginal tape

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Stress incontinence [ Time Frame: One year post operation ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Surgical complications [ Time Frame: one year ] [ Designated as safety issue: No ]
    Surgical complication

  • post surgery urgency or urge incontinence [ Time Frame: one year ] [ Designated as safety issue: No ]
    urgency or urge incontinence


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control arm
vaginal wall repair surgery will be done to women in this arm, with no treatment for stress incontinence
Active Comparator: TVT-O arm
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
during the vaginal wall repair surgery, a TVT-O procedure will be done
Other Name: GYNECARE TVT™ Obturator System

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507714

Locations
Israel
Dep of OG/GYN, Emek Medical Center Not yet recruiting
Afula, Israel
Contact: MEIRAV BRAVERMAN, MD     0509384595     meiraval@clalit.org.il    
Principal Investigator: Meirav Braverman, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: MEIRAV BRAVERMAN, MD HaEmek Medical Center, Afula, Israel
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01507714     History of Changes
Other Study ID Numbers: 0083-11EMC
Study First Received: January 2, 2012
Last Updated: January 8, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Preventive
tvt-o
stress incontinence

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urinary Incontinence
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013