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Randomized Controlled Trial
. 2011 Jul;22(7):827-33.
doi: 10.1007/s00192-011-1380-9. Epub 2011 Mar 2.

Contasure-Needleless compared with transobturator-TVT for the treatment of stress urinary incontinence

Lluís Amat I Tardiu  1 , Eva Martínez Franco, Josep Maria Laïlla Vicens
Affiliations
Randomized Controlled Trial

Contasure-Needleless compared with transobturator-TVT for the treatment of stress urinary incontinence

Lluís Amat I Tardiu et al. Int Urogynecol J. 2011 Jul.

Abstract

Introduction: Single-incision devices for the treatment of stress urinary incontinence (SUI) have been introduced in the last few years. We report a comparison between Obturator Tension-free vaginal tape (TVT-O) and Contasure-Needleless (C-NDL).

Methods: One hundred and fifty-eight women with primary SUI were scheduled to receive TVT-O or C-NDL and follow-up during the first year. Epidemiological information, complications, blood loss, and pain level were recorded. We also analyze stress test and quality of life.

Results: Sixty-three (87.5%) C-NDL presented a negative stress test, compared with 54 (90%) of TVT-O (p value 0.015 for non-inferiority test). Sandvik Severity Index was 0 in 75.4% in the C-NDL group and 87.3% in the TVT-O (p < 0.015). Complication rate and degree of satisfaction were similar in both groups. Statistically, there were differences (p = 0.012) in postoperative pain in the TVT-O group.

Conclusions: C-NDL provides similar outcomes as TVT-O after 1-year follow-up. It is necessary that long-term data confirm our results.

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