Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

This study has been completed.
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00223106
First received: September 12, 2005
Last updated: March 17, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Urinary Incontinence, Stress
Mixed Incontinence
Vaginal Vault Prolapse
Device: Vaginal Sling
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Covidien:

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

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

Study Start Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223106

Locations
United States, Connecticut
US Surgical
Norwalk, Connecticut, United States, 06856
Sponsors and Collaborators
Covidien
Investigators
Study Director: Noreen A. Gannon Covidien
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223106     History of Changes
Other Study ID Numbers: WHC03001
Study First Received: September 12, 2005
Last Updated: March 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
urge incontinence
urinary incontinence
vault prolapse
stess incontinence
mixed incontinence
urine leakage
enterocele
rectocele
cystocele

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014