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Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

Primary Purpose

Urinary Stress Incontinence

Status
Unknown status
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
TVT and TVT-O minimally invasive surgical procedures
Surgery for female stress urinary incontinence
Sponsored by
University of Helsinki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Incontinence, Urinary, Female, Surgery, Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital

Outcomes

Primary Outcome Measures

Complications
Objective cure rate by stress test and pad weighing test

Secondary Outcome Measures

Quality of life questionnaires

Full Information

First Posted
September 19, 2006
Last Updated
October 31, 2006
Sponsor
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT00379314
Brief Title
Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence
Official Title
A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Helsinki

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Incontinence, Urinary, Female, Surgery, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
TVT and TVT-O minimally invasive surgical procedures
Intervention Type
Procedure
Intervention Name(s)
Surgery for female stress urinary incontinence
Primary Outcome Measure Information:
Title
Complications
Title
Objective cure rate by stress test and pad weighing test
Secondary Outcome Measure Information:
Title
Quality of life questionnaires

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl G Nilsson, MD,PhD
Organizational Affiliation
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carl G Nilsson, MD,PhD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
11942891
Citation
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.
Results Reference
background
PubMed Identifier
24508070
Citation
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.
Results Reference
derived
PubMed Identifier
17197581
Citation
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.
Results Reference
derived
Links:
URL
http://www.iuga.org/
Description
International urogynecological association

Learn more about this trial

Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

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