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75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial.

Abstract：

INTRODUCTION AND HYPOTHESIS:Management of stress urinary incontinence (SUI) with intravaginal devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 intravaginal device for SUI management. METHODS:A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted. RESULTS:Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (-31.7 ± 65.1 % vs -7.6 ± 24.5 %, p = 0.002, -2.4 ± 2.6 vs 0.2 ± 2.2, p = 0.004, and -1.5 ± 2.8 vs 0.2 ± 1.8, p = 0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study. CONCLUSIONS:The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.

journal_name

Int Urogynecol J

journal_title

International urogynecology journal

authors

Cornu JN,Mouly S,Amarenco G,Jacquetin B,Ciofu C,Haab F,75NC007 Study Group.

doi

10.1007/s00192-012-1814-z

subject

Has Abstract

pub_date

2012-12-01 00:00:00

pages

1727-34

issue

12

eissn

0937-3462

issn

1433-3023

journal_volume

23

pub_type

杂志文章,多中心研究,随机对照试验

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