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

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00196521
Collaborator
(none)
300
Enrollment
19
Locations
25.9
Duration (Months)
15.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Tension-free vaginal tape obturator system
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2005
Study Completion Date :
Mar 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urogynecology Associates of CO Denver Colorado United States 80220
2 Bladder Control Center Norwalk Connecticut United States 06850
3 Urogynecology Specialists of Kenuckiana Louisville Kentucky United States 40207
4 Greater Baltimore Medical Center Baltimore Maryland United States 21204
5 Oakwood Hospital Dearborn Michigan United States 48123
6 Sheldon Freedman, MD Las Vegas Nevada United States 89109
7 St. Peter's University Hospital New Brunswick New Jersey United States 08901
8 The Institute for Female Pelvic Medicine & Reconstructive Surgery Allentown Pennsylvania United States 18104
9 University Urology Knoxville Tennessee United States 37920
10 McDonlad Murrmann Women's Clinic Memphis Tennessee United States 38120
11 Sound Urology Ambulatory Surgery Center Edmonds Washington United States 98026
12 Sunnybrook & Women's College Health Sciences Center Toronto Ontario Canada M2L 1V7
13 Service d'Urologie Marseille France 13015
14 Hopital Des Diaconesses Paris France 75571
15 Klinikum der Eberhard-Karls-Universität Tubingen Germany D-72706
16 Samsung Medical Center Seoul Korea, Republic of 135-710
17 University of Ulsan College of Medicine and Asan Medical Center Seoul Korea, Republic of
18 Women's and Children's Hospital Singapore Singapore 229 899
19 Southport District General Hospital Southport United Kingdom PR8 6PN

Sponsors and Collaborators

  • Ethicon, Inc.

Investigators

  • Study Director: Martin Weisberg, MD, Ethicon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00196521
Other Study ID Numbers:
  • 300-04-004
First Posted:
Sep 20, 2005
Last Update Posted:
Dec 13, 2007
Last Verified:
Mar 1, 2007
Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress

Study Results

No Results Posted as of Dec 13, 2007