Clinical trial NCT00379314: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Urinary Stress Incontinence
Keywords: Incontinence
Urinary
Female
Surgery
Complications
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2006-09-21
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complications
measure: Objective cure rate by stress test and pad weighing test
Secondary outcomes:
measure: Quality of life questionnaires
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
name: Carl G Nilsson, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Carl G Nilsson, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.