Status:
COMPLETED
Retropubic vs. Transobturator Tension-free Vaginal Tape
Lead Sponsor:
Austrian Urogynecology Working Group (AUWG)
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is pl...
Detailed Description
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.
Eligibility Criteria
Inclusion
- Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
- Patient able and willing to participate in follow-up
- Informed consent
Exclusion
- ´
- Detrusor overactivity, predominant complaint overactive bladder (OAB)
- Major concomitant surgery
- Prolapse beyond introitus or any prolapse necessitating surgery
- Previous incontinence surgery other than colporrhaphy
- Residual urine \>100 ml
- Neurologic disease
- Allergy to local anesthetic agents
- Coagulation disorders
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT00441454
Start Date
September 1 2004
End Date
October 1 2012
Last Update
December 11 2012
Active Locations (4)
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1
Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
Graz, Austria, 8020
2
Department of OB/GYN, Medical University of Graz
Graz, Austria, 8036
3
Dept. OB/GYN, Medical University of Vienna
Vienna, Austria, 1090
4
Dept. OB/GYN, Wilhelminenspital
Vienna, Austria, 1160