Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

Sponsor

Medtronic - MITG (Industry)

Overall Status

Completed

CT.gov ID

NCT00223106

Collaborator

(none)

467

Enrollment

Location

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Stress Mixed Incontinence Vaginal Vault Prolapse	Device: Vaginal Sling	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

467 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Safety and efficacy for incontinence and prolapse procedures. []

Secondary Outcome Measures

Quality of Life Improvement as determined by Questionnaire. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject must be female and >18 years of age.
Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.

Exclusion Criteria:

Any subject with clotting defects, bleeding disorders or receiving anticoagulant treatments AND is determined to be at risk for minimally invasive surgery as determined by the investigator
Subjects who currently have an untreated urinary tract infection
Subject is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent.
Subject is pregnant or desires future pregnancies.