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

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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.

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Acknowledgments

The authors thank B.BRAUN Medical SAS for their funding support.

The authors thank the other 75NC001 Study Group investigators who participated in the conduct of the trial included the following: O. Chevallier, MD, Paris, France; P. Grise, MD, Rouen, France; JF Hermieu, MD, Paris, France; C Jouffroy, MD, Metz, France; L. Lenormand, MD, Nantes, France; C Marhic, MD, Vincennes, France; T Mouchel, MD, Le Mans, France; JL Pouch, MD, Paris, France.

Conflicts of interest

Professor Stephane Mouly received consultancy honoraria from B. Braun, Pfizer, Sanofi-Aventis, Lilly Research Laboratories, Lundbeck and Chugai Pharma. Other authors have no conflicts of interest to declare.

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Authors and Affiliations

  1. Department of Urology, Tenon Hospital, Assistance Publique-Hôpitaux de Paris, University Pierre-et-Marie-Curie Paris 6, 4 rue de la chine, 75020, Paris, France

    Jean-Nicolas Cornu, Calin Ciofu & Francois Haab

  2. Department of Internal Medicine, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, University Sorbonne Paris Cité-Diderot, 2 rue Ambroise Paré, 75010, Paris, France

    Stéphane Mouly

  3. GREEN Groupe de recherche clinique en neuro-urologie, GRC UPMC, University Pierre-et-Marie-Curie Paris 6, Neuro-urology Unit, Tenon Hospital, Assistance Publique-Hôpitaux de Paris, 4 rue de la Chine, 75020, Paris, France

    Gérard Amarenco

  4. Uro-gynecology Unit, CHU Estaing 1, place Lucie-Aubrac, 63100, Clermont-Ferrand, France

    Bernard Jacquetin

  5. Urology Department, Tenon Hospital, 4 rue de la Chine, 75970, Paris Cedex 20, France

    Jean-Nicolas Cornu

Authors
  1. Jean-Nicolas Cornu
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  2. Stéphane Mouly
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  3. Gérard Amarenco
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  4. Bernard Jacquetin
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  5. Calin Ciofu
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  6. Francois Haab
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the 75NC007 Study Group

Corresponding author

Correspondence to Jean-Nicolas Cornu.

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Cornu, JN., Mouly, S., Amarenco, G. et al. 75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial. Int Urogynecol J 23, 1727–1734 (2012). https://doi.org/10.1007/s00192-012-1814-z

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  • DOI: https://doi.org/10.1007/s00192-012-1814-z

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