A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)

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: NCT00196521
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 13, 2007
Information provided by:
Ethicon, Inc.

Brief Summary:
Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Tension-free vaginal tape obturator system Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence
Study Start Date : January 2005
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Overall incidence of treatment success.

Secondary Outcome Measures :
  1. Assessment of unresolved de novo urgency post-treatment.
  2. No additional surgery required to correct SUI post-treatment
  3. Intraoperative and postoperative complications
  4. Quality-of-life measurements
  5. Return to usual activity
  6. Patient satisfaction

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
  • Patient is age 18 or older.
  • Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
  • Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.

Exclusion Criteria:

  • Patient has an associated or suspected neurological disease.
  • Patient is on anti-coagulation therapy.
  • Patient has received an investigational drug or device in the past 60 days.

For patients having URP measurements at selected sites:

  • Patient has an active lesion or present injury to perineum or urethra.Patient has a urethral obstruction.
  • Patient has an unreduced cystocele > Stage 1. (Reduction of prolapse prior to URP testing is required.) Reduction of Cystocele (if applicable). Patients should be seated in a semi-fowler's position with head of bed at 40-60 degrees.

Carefully place a half of a speculum into the vagina, reducing prolapse to less than stage 1. Be careful not to over extend or elongate the vaginal length.

The half of a speculum must be placed with pressure emphasis on the posterior and apical areas. Anterior wall pressure or urethral pressure must be avoided at all times.

  • The subject has active infection upon urine dipstick analysis, defined as ≥+1 leukocytes or ≥+1 nitrates (Must reschedule appointment after UTI resolves.)

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): NCT00196521

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Sponsors and Collaborators
Ethicon, Inc.
Study Director: Martin Weisberg, MD Ethicon, Inc.

Responsible Party: Ethicon, Inc. Identifier: NCT00196521     History of Changes
Other Study ID Numbers: 300-04-004
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders