Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Helsinki University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Helsinki University
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00379314
First received: September 19, 2006
Last updated: October 31, 2006
Last verified: September 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Stress Incontinence |
Procedure: TVT and TVT-O minimally invasive surgical procedures Procedure: Surgery for female stress urinary incontinence |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence |
Resource links provided by NLM:
Further study details as provided by Helsinki University:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379314
Locations
| Finland | |
| Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital | |
| Helsinki, Finland, 00029 HUS | |
Sponsors and Collaborators
Helsinki University
Investigators
| Principal Investigator: | Carl G Nilsson, MD,PhD | Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital |
| Principal Investigator: | Carl G Nilsson, MD,PhD | Helsinki University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00379314 History of Changes |
| Other Study ID Numbers: | 42/E8/04 |
| Study First Received: | September 19, 2006 |
| Last Updated: | October 31, 2006 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Helsinki University:
|
Incontinence Urinary Female Surgery Complications |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013