Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

July 23, 2015 updated by: Medtronic - MITG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

467

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • US Surgical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and efficacy for incontinence and prolapse procedures.

Secondary Outcome Measures

Outcome Measure
Quality of Life Improvement as determined by Questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Study Director: Noreen A. Gannon, Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHC03001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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