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

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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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Conflicts of interest

C.G.N. has acted as consultant for Astellas, Ethicon and Pfizer. A.V. has acted as consultant for Astellas Ethicon and Pfizer. This study was instigated by the responsible researchers and funded by University-Administered funds.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Helsinki University Central Hospital, POB 140 Haartmaninkatu 2, 00029, Helsinki, Finland

    Kirsi Palva & Carl Gustaf Nilsson

  2. Obstetrics and Gynecology, Kuopio University Hospital, Kuopio, Finland

    Kirsi Rinne

  3. Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland

    Eija Laurikainen

  4. Department of Obstetrics and Gynecology, Central Finland Central Hospital, Jyväskylä, Finland

    Pauliina Aukee

  5. Department of Obstetrics and Gynecology, Oulu University Hospital, Oulu, Finland

    Aarre Kivelä

  6. Department of Obstetrics and Gynecology, Päijät-Häme Central Hospital, Lahti, Finland

    Teuvo Takala

  7. Department of Obstetrics and Gynecology, South-Carelian Central Hospital, Lappeenranta, Finland

    Antti Valpas

Authors
  1. Kirsi Palva
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  2. Kirsi Rinne
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  3. Pauliina Aukee
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  4. Aarre Kivelä
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  5. Eija Laurikainen
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  6. Teuvo Takala
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  7. Antti Valpas
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  8. Carl Gustaf Nilsson
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Corresponding author

Correspondence to Carl Gustaf Nilsson.

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Palva, K., Rinne, K., Aukee, P. et al. A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results. Int Urogynecol J 21, 1049–1055 (2010). https://doi.org/10.1007/s00192-010-1160-y

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  • DOI: https://doi.org/10.1007/s00192-010-1160-y

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