Stress Urinary IncontinenceNCT00453739
TVT Worldwide Registry
An observational study of Stress Urinary Incontinence, run by Ethicon, Inc. at 30 sites in 9 countries.
Trial summary
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 1,407 participants
- Where
- 30 sitesin 9 countries
- Study dates
- Feb 2007to Jun 2010
- Phase
- Observational
- 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
Study population: Women diagnosed with SUI who are suitable candidates for a TVT system, according the relevant Instructions for Use (IFU).
Who may be able to join
- Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Who cannot join
None listed.
Trial locations and contacts
30 sites in 9 countries.
30 sites in 9 countries
United States15 sites
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18104
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, 22003
Michigan Institute of Women's Health
Dearborn, Michigan, 48124
Southern California Permanente Medical Group
Downey, California, 91101
Sound Urological Associates
Edmonds, Washington, 98026
Milestone Medical Research
Englewood, Colorado, 80112
Women's Health Center of West Michigan
Grand Rapids, Michigan, 49503
Sheldon J. Freedman MD
Las Vegas, Nevada, 89148
Female Pelvic Medicine & Reconstructive Surgery
Minneapolis, Minnesota, 55403
Specialists in Urology
Naples, Florida, 34102
Vanderbilt University Medical School
Nashville, Tennessee, 37232
Illinois Urogynecology LTD
Oak Lawn, Illinois, 60453
University of Rochester OB/Gyn Department
Rochester, New York, 14642
Seton Center, Good Samaritan Hospital
West Chester, Ohio, 45069
Advanced Clinical Concepts
West Reading, Pennsylvania, 19611
United Kingdom4 sites
Ulster Hospital Belfast
Belfast
Stoke Mandeville Hospital
Buckinghamshire, HP21 8AL
Glasgow Southern General
Glasgow, G51 4TF
Leicester General Hospital
Leicester, LE5 4PW
Australia3 sites
The Townsville Hospital Department of Urogynaecology
Douglas
Gold Coast Health Service
Southport
Queen Elizabeth Hospital
Woodville
South Africa3 sites
Kingsbury House
Cape Town, 7708
Pretoria Urology Hospital
Hatfield, 0028
Arwyp Hospital
Kempton, 1620
Singapore1 site
Kandang Kerbau Women's and Children's Hospital
Singapore, 229 899
About this study
Official title: TVT-World Wide Observational Registry for Long-Term Data
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.
Read the detailed description
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System
- Conditions
- Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Standing cough stress test
Measured: 12 months
Secondary outcomes (1)
I-QOL score
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Robinson, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453739
- Sponsor's protocol ID
- 300-06-006
- Status last verified
- May 2014
- First submitted
- 28 Mar 2007
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tincello DG, Botha T, Grier D, Jones P, Subramanian D, Urquhart C, Kirkemo A, Khandwala S; TVT Worldwide Registry Investigators. The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. J Urol. 2011 Dec;186(6):2310-5. doi: 10.1016/j.juro.2011.07.078. Epub 2011 Oct 20.
PubMed 22014817
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVT-World Wide Observational Registry for Long-Term Data
- ClinicalTrials.gov ID
- NCT00453739
- Acronym / sponsor ID
- 300-06-006
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,407 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Mar 2007 (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.
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.
Detailed description
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with SUI who are suitable candidates for a TVT system, according the relevant Instructions for Use (IFU).
Key inclusion criteria (1 listed)
- Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standing cough stress test
Time frame: 12 months
1 secondary outcome
I-QOL score
Time frame: 3, 6, 12 and 24 months
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 6 May 2014.
- Results publication: PubMed 22014817Tincello DG, Botha T, Grier D, Jones P, Subramanian D, Urquhart C, Kirkemo A, Khandwala S; TVT Worldwide Registry Investigators. The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. J Urol. 2011 Dec;186(6):2310-5. doi: 10.1016/j.juro.2011.07.078. Epub 2011 Oct 20.
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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.
David Robinson, MD study director
Ethicon, Inc.
30 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Ethicon, Inc. at 30 sites in 9 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 1 inclusion and 0 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, United Kingdom, Australia, South Africa, Austria and 4 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?
Standing cough stress test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453739, which also lists 1 linked publication.
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 6 May 2014.