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

NCT00196521 | Completed

• 1 other identifier: 300-04-004
• Study Type: interventional
• Target: 300
• Locations: 7 countries
• Sites: 19

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Overall incidence of treatment success.

Secondary Outcomes (6)

• Assessment of unresolved de novo urgency post-treatment.

• No additional surgery required to correct SUI post-treatment

• Intraoperative and postoperative complications

• Quality-of-life measurements

• Return to usual activity

Interventions

Tension-free vaginal tape obturator system DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (19)

Urogynecology Associates of CO

Denver, Colorado, 80220, United States

Location

Bladder Control Center

Norwalk, Connecticut, 06850, United States

Location

Urogynecology Specialists of Kenuckiana

Louisville, Kentucky, 40207, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48123, United States

Location

Sheldon Freedman, MD

Las Vegas, Nevada, 89109, United States

Location

St. Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

The Institute for Female Pelvic Medicine & Reconstructive Surgery

Allentown, Pennsylvania, 18104, United States

Location

University Urology

Knoxville, Tennessee, 37920, United States

Location

McDonlad Murrmann Women's Clinic

Memphis, Tennessee, 38120, United States

Location

Sound Urology Ambulatory Surgery Center

Edmonds, Washington, 98026, United States

Location

Sunnybrook & Women's College Health Sciences Center

Toronto, Ontario, M2L 1V7, Canada

Location

Service d'Urologie

Marseille, 13015, France

Location

Hopital Des Diaconesses

Paris, 75571, France

Location

Klinikum der Eberhard-Karls-Universität

Tübingen, D-72706, Germany

Location

Women's and Children's Hospital

Singapore, 229 899, Singapore

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

University of Ulsan College of Medicine and Asan Medical Center

Seoul, South Korea

Location

Southport District General Hospital

Southport, PR8 6PN, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Weisberg, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Study Completion: March 1, 2007
• Last Updated: December 13, 2007

Record last verified: 2007-03

Locations

US (11); KR (2); FR (2); CA (1); DE (1); SG (1); GB (1)