Urinary Incontinence, Stress Clinical Trial
Official title:
A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed 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 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.
Prolapse
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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