NCT00379314

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 1, 2006

Status Verified

September 1, 2006

First QC Date

September 19, 2006

Last Update Submit

October 31, 2006

Conditions

Urinary Stress Incontinence

Keywords

IncontinenceUrinaryFemaleSurgeryComplications

Outcome Measures

Primary Outcomes (2)

  • Complications

  • Objective cure rate by stress test and pad weighing test

Secondary Outcomes (1)

  • Quality of life questionnaires

Interventions

TVT and TVT-O minimally invasive surgical proceduresPROCEDURE
Surgery for female stress urinary incontinencePROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of stress incontinence
  • indications for surgical treatment
  • positive cough stress test
  • urgency score \< 7

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital

Helsinki, 00029 HUS, Finland

Location

Related Publications (3)

  • 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.

    PMID: 11942891BACKGROUND

  • 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.

    PMID: 24508070DERIVED

  • 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.

    PMID: 17197581DERIVED

Related Links

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carl G Nilsson, MD,PhD

    Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

  • Carl G Nilsson, MD,PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

April 1, 2004

Study Completion

December 1, 2010

Last Updated

November 1, 2006

Record last verified: 2006-09

Locations

FI(1)