Stress Urinary IncontinenceNCT00196521
A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
A study testing Tension-free vaginal tape obturator system in people with Stress Urinary Incontinence, run by Ethicon, Inc. at 19 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Tension-free vaginal tape obturator system
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 19 sitesin 7 countries
- Study dates
- Jan 2005to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.)
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
United States11 sites
The Institute for Female Pelvic Medicine & Reconstructive Surgery
Allentown, Pennsylvania, 18104
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Oakwood Hospital
Dearborn, Michigan, 48123
Urogynecology Associates of CO
Denver, Colorado, 80220
Sound Urology Ambulatory Surgery Center
Edmonds, Washington, 98026
University Urology
Knoxville, Tennessee, 37920
Sheldon Freedman, MD
Las Vegas, Nevada, 89109
Urogynecology Specialists of Kenuckiana
Louisville, Kentucky, 40207
McDonlad Murrmann Women's Clinic
Memphis, Tennessee, 38120
St. Peter's University Hospital
New Brunswick, New Jersey, 08901
Bladder Control Center
Norwalk, Connecticut, 06850
France2 sites
Service d'Urologie
Marseille, 13015
Hopital Des Diaconesses
Paris, 75571
South Korea2 sites
Samsung Medical Center
Seoul, 135-710
University of Ulsan College of Medicine and Asan Medical Center
Seoul
Canada1 site
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, M2L 1V7
United Kingdom1 site
Southport District General Hospital
Southport, PR8 6PN
About this study
Official title: A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence
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
- Being tested
- Tension-free vaginal tape obturator system
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension-free vaginal tape obturator systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196521
- Sponsor's protocol ID
- 300-04-004
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 13 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00196521
- Acronym / sponsor ID
- 300-04-004
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Mar 2007
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tension-free vaginal tape obturator system | Device | – |
Primary outcome
Overall incidence of treatment success.
6 secondary outcomes
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
Patient satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Weisberg, MD study director
Ethicon, Inc.
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension-free vaginal tape obturator system in people with Stress Urinary Incontinence, run by Ethicon, Inc. at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France, South Korea, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of treatment success.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2007; AzTrials last refreshed its copy on 8 Nov 2026.