Pelvic Organ Prolapse Clinical Trial
Official title:
Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Dep of OG/GYN, Emek Medical Center | Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
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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