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Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00223106
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 27, 2015
Information provided by:
Medtronic - MITG

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 Not Applicable

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.


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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Study Type : Interventional  (Clinical Trial)
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 : March 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety and efficacy for incontinence and prolapse procedures.

Secondary Outcome Measures :
  1. Quality of Life Improvement as determined by Questionnaire.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00223106

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United States, Connecticut
US Surgical
Norwalk, Connecticut, United States, 06856
Sponsors and Collaborators
Medtronic - MITG
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Study Director: Noreen A. Gannon Medtronic - MITG

Layout table for additonal information Identifier: NCT00223106     History of Changes
Other Study ID Numbers: WHC03001
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Medtronic - MITG:
urge incontinence
urinary incontinence
vault prolapse
stess incontinence
mixed incontinence
urine leakage
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical