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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00453739




Registration number
NCT00453739
Ethics application status
Date submitted
28/03/2007
Date registered
29/03/2007
Date last updated
6/05/2014

Titles & IDs
Public title
TVT Worldwide Registry
Scientific title
TVT-World Wide Observational Registry for Long-Term Data
Secondary ID [1] 0 0
300-06-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Urinary Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Standing cough stress test
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
I-QOL score
Timepoint [1] 0 0
3, 6, 12 and 24 months

Eligibility
Key inclusion criteria
* Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
1407
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Townsville Hospital Department of Urogynaecology - Douglas
Recruitment hospital [2] 0 0
Gold Coast Health Service - Southport
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
- Douglas
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Austria
State/province [14] 0 0
Moedling
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Germany
State/province [16] 0 0
Tubingen
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Singapore
State/province [18] 0 0
Singapore
Country [19] 0 0
South Africa
State/province [19] 0 0
Cape Town
Country [20] 0 0
South Africa
State/province [20] 0 0
Hatfield
Country [21] 0 0
South Africa
State/province [21] 0 0
Kempton
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Belfast
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Buckinghamshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Glasgow
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00453739
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
David Robinson, MD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00453739