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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01507714
Other study ID # 0083-11EMC
Secondary ID
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


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
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Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A