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TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial

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Abstract

Introduction and hypothesis

Before the introduction of the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence, the colposuspension operation was regarded as the “gold standard” procedure. The laparoscopic variant of the colposuspension was introduced as a less invasive operation. The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension (LCM).

Methods

A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence. Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence. Patient satisfaction was assessed by Patients Global Impression of Improvement, a visual analog scale, and the Urinary Incontinence Severity Score.

Results

Of 128 randomized patients, 121 underwent the allocated operation. At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol. The objective cure rate was significantly higher in the TVT group (94 %) than in the LCM group (78 %). Subjective treatment satisfaction (completely satisfied with the procedure) was significantly higher in the TVT group (64 %) than in the LCM group (51 %).

Conclusions

By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group. If cases that were lost to follow-up were regarded as failures, the intension-to-treat analysis found no difference between the groups.

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Conflicts of interest

A. Valpas, S. Ala-Nissilä, and E. Tomas: none; C.G. Nilsson: travel expenses and honoraria, consultant for Astellas.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, South-Karelian Central Hospital, Lappenranta, Finland

    A. Valpas

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

    S. Ala-Nissilä

  3. Department of Obstetrics and Gynecology, University of Tampere, Tampere, Finland

    E. Tomas

  4. Department of Obstetrics and Gynecology, Helsinki University Central Hospital, HUS, POB 140, 00029, Helsinki, Finland

    C. G. Nilsson

Authors
  1. A. Valpas
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  2. S. Ala-Nissilä
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  3. E. Tomas
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  4. C. G. Nilsson
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Corresponding author

Correspondence to C. G. Nilsson.

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Valpas, A., Ala-Nissilä, S., Tomas, E. et al. TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial. Int Urogynecol J 26, 57–63 (2015). https://doi.org/10.1007/s00192-014-2454-2

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  • DOI: https://doi.org/10.1007/s00192-014-2454-2

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