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

NCT ID: NCT00379314

Last Updated: 2006-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Stress Incontinence

Keywords

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Incontinence Urinary Female Surgery Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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TVT and TVT-O minimally invasive surgical procedures

Intervention Type PROCEDURE

Surgery for female stress urinary incontinence

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Principal Investigators

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Carl G Nilsson, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital

Carl G Nilsson, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

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Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 11942891 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24508070 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17197581 (View on PubMed)

Related Links

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http://www.iuga.org/

International urogynecological association

Other Identifiers

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42/E8/04

Identifier Type: -

Identifier Source: org_study_id