Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence
October 31, 2006 updated by: University of Helsinki
A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence.
The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications.
A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications.
The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment
260
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland, 00029 HUS
- Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- history of stress incontinence
- indications for surgical treatment
- positive cough stress test
- urgency score < 7
Exclusion Criteria:
- prior incontinence surgery
- need of concomitant surgery
- post void residual urine volume < 100 ml
- urinary tract anomalies
- urinary tract infection
- more than 3 urinary tract infection within last year
- more than grade 2 urogenital prolapse
- Body mass index > 35
- Radiotherapy of the pelvic region
- active malignancy
- hemophilia
- anticoagulant treatment
- neurological disorder or other disease which affects bladder function
- anticholinergic treatment
- use of duloxetine
- do not understand the purpose of the trial
- immobility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Complications
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Objective cure rate by stress test and pad weighing test
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Secondary Outcome Measures
Outcome Measure |
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Quality of life questionnaires
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carl G Nilsson, MD,PhD, Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
- Principal Investigator: Carl G Nilsson, MD,PhD, University of Helsinki
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.
- Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, Takala T, Nilsson CG. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014 Jun;65(6):1109-14. doi: 10.1016/j.eururo.2014.01.031. Epub 2014 Jan 31.
- Laurikainen E, Valpas A, Kivela A, Kalliola T, Rinne K, Takala T, Nilsson CG. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):4-11. doi: 10.1097/01.AOG.0000249607.82768.a1.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Study Completion
December 1, 2010
Study Registration Dates
First Submitted
September 19, 2006
First Submitted That Met QC Criteria
September 19, 2006
First Posted (Estimate)
September 21, 2006
Study Record Updates
Last Update Posted (Estimate)
November 1, 2006
Last Update Submitted That Met QC Criteria
October 31, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 42/E8/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.