Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.
Urinary Incontinence, Stress
Vaginal Vault Prolapse
Device: Vaginal Sling
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse|
- Safety and efficacy for incontinence and prolapse procedures.
- Quality of Life Improvement as determined by Questionnaire.
|Study Start Date:||March 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Urinary incontinence is the involuntary loss of urine and can affect both men and women throughout their lives. Women are more likely to develop incontinence as a result of pregnancy and childbirth. There are approximately 11 million cases of incontinence in the US contributing to several different types of incontinence including :
- Urge - 30% of the market
- Stress - 30% of the market of which 85% are women
- Combination urge and stress - 40%
Despite advances in behavioral therapy, pharmacological advances as well as development of minimally invasive surgical procedures, only one out of every twelve people affected actually seek help.
Globally, approximately 1 million women suffer uterovaginal prolapse annually and this condition can be associated with urinary incontinence. The breakdown of treatments for uterovaginal prolapse includes:
- 20% - no treatment
- 20% - non surgical management (pessary)
- 60% - receive a surgical procedure of a suture repair or mesh repair
There were greater than 600,000 surgeries performed globally to treat prolapse. These numbers are projected to increase due to rapid, easy, and less costly methods as well as new products that facilitate the easier procedures.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223106
|United States, Connecticut|
|Norwalk, Connecticut, United States, 06856|
|Study Director:||Noreen A. Gannon||Medtronic - MITG|