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01.09.2010 | Original Article

A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results

verfasst von: Kirsi Palva, Kirsi Rinne, Pauliina Aukee, Aarre Kivelä, Eija Laurikainen, Teuvo Takala, Antti Valpas, Carl Gustaf Nilsson

Erschienen in: International Urogynecology Journal | Ausgabe 9/2010

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Abstract

Introduction and hypothesis

This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate.

Methods

Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires.

Results

At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups.

Conclusion

The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

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Titel: A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results
verfasst von: Kirsi Palva
Kirsi Rinne
Pauliina Aukee
Aarre Kivelä
Eija Laurikainen
Teuvo Takala
Antti Valpas
Carl Gustaf Nilsson
Publikationsdatum: 01.09.2010
Verlag: Springer-Verlag
Erschienen in: International Urogynecology Journal / Ausgabe 9/2010
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-010-1160-y

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A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results