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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196521
• Other study ID #: 300-04-004
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 11, 2007
• Start date: January 2005
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Tension-free vaginal tape obturator system

Locations

Country	Name	City	State
Canada	Sunnybrook & Women's College Health Sciences Center	Toronto	Ontario
France	Service d'Urologie	Marseille
France	Hopital Des Diaconesses	Paris
Germany	Klinikum der Eberhard-Karls-Universität	Tubingen
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	University of Ulsan College of Medicine and Asan Medical Center	Seoul
Singapore	Women's and Children's Hospital	Singapore
United Kingdom	Southport District General Hospital	Southport
United States	The Institute for Female Pelvic Medicine & Reconstructive Surgery	Allentown	Pennsylvania
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Oakwood Hospital	Dearborn	Michigan
United States	Urogynecology Associates of CO	Denver	Colorado
United States	Sound Urology Ambulatory Surgery Center	Edmonds	Washington
United States	University Urology	Knoxville	Tennessee
United States	Sheldon Freedman, MD	Las Vegas	Nevada
United States	Urogynecology Specialists of Kenuckiana	Louisville	Kentucky
United States	McDonlad Murrmann Women's Clinic	Memphis	Tennessee
United States	St. Peter's University Hospital	New Brunswick	New Jersey
United States	Bladder Control Center	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Korea, Republic of,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall incidence of treatment success.
Secondary	Assessment of unresolved de novo urgency post-treatment.
Secondary	No additional surgery required to correct SUI post-treatment
Secondary	Intraoperative and postoperative complications
Secondary	Quality-of-life measurements
Secondary	Return to usual activity
Secondary	Patient satisfaction