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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Preventive transobturator tension free vaginal tape
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Preventive, tvt-o, stress incontinence

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Dep of OG/GYN, Emek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control arm

TVT-O arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Surgical complications
Surgical complication
post surgery urgency or urge incontinence
urgency or urge incontinence

Full Information

First Posted
January 2, 2012
Last Updated
January 8, 2012
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT01507714
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Preventive, tvt-o, stress incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control arm
Arm Type
No Intervention
Arm Description
vaginal wall repair surgery will be done to women in this arm, with no treatment for stress incontinence
Arm Title
TVT-O arm
Arm Type
Active Comparator
Arm Description
the women in this arm will have a TVT-O procedure in addition to the vaginal wall repair
Intervention Type
Procedure
Intervention Name(s)
Preventive transobturator tension free vaginal tape
Other Intervention Name(s)
GYNECARE TVT™ Obturator System
Intervention Description
during the vaginal wall repair surgery, a TVT-O procedure will be done
Primary Outcome Measure Information:
Title
Stress incontinence
Description
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
Time Frame
One year post operation
Secondary Outcome Measure Information:
Title
Surgical complications
Description
Surgical complication
Time Frame
one year
Title
post surgery urgency or urge incontinence
Description
urgency or urge incontinence
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MEIRAV BRAVERMAN, MD
Organizational Affiliation
HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep of OG/GYN, Emek Medical Center
City
Afula
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MEIRAV BRAVERMAN, MD
Phone
0509384595
Email
meiraval@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Meirav Braverman, MD

12. IPD Sharing Statement

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

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