Clinical trial NCT00196521: A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
Official title: A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Overall incidence of treatment success.
Secondary outcomes:
measure: Assessment of unresolved de novo urgency post-treatment.
measure: No additional surgery required to correct SUI post-treatment
measure: Intraoperative and postoperative complications
measure: Quality-of-life measurements
measure: Return to usual activity
measure: Patient satisfaction
Other outcomes:
Locations:
city: Denver
country: United States
facility: Urogynecology Associates of CO
state: Colorado
city: Norwalk
country: United States
facility: Bladder Control Center
state: Connecticut
city: Louisville
country: United States
facility: Urogynecology Specialists of Kenuckiana
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Las Vegas
country: United States
facility: Sheldon Freedman, MD
state: Nevada
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery
state: Pennsylvania
city: Knoxville
country: United States
facility: University Urology
state: Tennessee
city: Memphis
country: United States
facility: McDonlad Murrmann Women's Clinic
state: Tennessee
city: Edmonds
country: United States
facility: Sound Urology Ambulatory Surgery Center
state: Washington
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Center
state: Ontario
city: Marseille
country: France
facility: Service d'Urologie
city: Paris
country: France
facility: Hopital Des Diaconesses
city: Tubingen
country: Germany
facility: Klinikum der Eberhard-Karls-Universität
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: University of Ulsan College of Medicine and Asan Medical Center
city: Singapore
country: Singapore
facility: Women's and Children's Hospital
city: Southport
country: United Kingdom
facility: Southport District General Hospital
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References: