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Outcome and Cost Analysis of Sacral Nerve Modulation for Treating Urinary and/or Fecal Incontinence

Leroi, Anne-Marie MD, PhD*; Lenne, Xavier MSc; Dervaux, Benoît PhD; Chartier-Kastler, Emmanuel MD, PhD§; Mauroy, Brigitte MD, PhD; Normand, Loïc Le MD, PhD|; Grise, Philippe MD, PhD**; Faucheron, Jean-Luc MD, PhD††; Parc, Yann MD, PhD‡‡; Lehur, Paul-Antoine MD, PhD§§; Mion, François MD, PhD¶¶; Damon, Henri MD¶¶; Barth, Xavier MD, PhD¶¶; Leriche, Albert MD, PhD||; Saussine, Christian MD, PhD***; Guy, Laurent MD, PhD†††; Haab, François MD, PhD‡‡‡; Bresler, Laurent MD, PhD§§§; Sarramon, Jean-Pierre MD, PhD¶¶¶; Bensadoun, Henri MD, PhD|||; Rullier, Eric MD, PhD****; Slim, Karem MD, PhD††††; Sielezneff, Igor MD, PhD‡‡‡‡; Mourey, Eric MD§§§§; Ballanger, Philippe MD, PhD¶¶¶¶; Michot, Francis MD, PhD*

doi: 10.1097/SLA.0b013e318210f1f4
Original Articles

Background: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed.

Objective: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments.

Methods: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio).

Results: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was € 8525 (95% confidence interval, € 6686–€ 10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was € 6581 (95% confidence interval, € 2077–€ 11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was € 94,204 and € 185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively.

Conclusions: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

The cost effectiveness of sacral nerve modulation (SNM) compared to alternative medical and surgical treatments was assessed in a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

*ADEN EA 3234/IFR MP 23, Rouen University Hospital, Rouen, France.

CRESGE-LEM (CNRS URA No. 362), Catholic University of Lille, Secteur PMSI, Lille University Hospital, Lille, France.

Université “Droit et Santé”—Lille 2, Faculty of Medicine, DRCI—Lille University Hospital, Lille, France.

§Urology Department, Pierre et Marie Curie Medical School, Paris VI, Paris, France.

Urology Department, Lille University Hospital GHICL, Lille, France.

|Urology Department, Nantes University Hospital, Nantes.

**Urology Department, Rouen University Hospital, Rouen, France.

††Digestive Surgery Department, Grenoble University Hospital, Grenoble, France.

‡‡Digestive Surgery Department, Saint-Antoine Hospital, Paris, France.

§§Digestive Surgery Department, Nantes University Hospital, Nantes, France.

¶¶Digestive Physiology Department, Edouard Herriot Hospital, Lyon, France.

||Urology Department, Henry Gabrielle Hospital, University of Lyon I, Lyon, France.

***Urology Department, Strasbourg University Hospital, Strasbourg, France.

†††Urology Department, Montpied Hospital, Clermont-Ferrand University, Clermont-Ferrand, France.

‡‡‡Urology Department, Tenon Hospital, Paris, France.

§§§Digestive Surgery Department, Nancy University Hospital, Nancy, France.

¶¶¶Urology Department, Rangueil Hospital, Toulouse, France.

|||Urology Department, Caen University Hospital, Caen, France.

****Digestive Surgery Department, Bordeaux University Hospital, Bordeaux, France.

††††Digestive Surgery Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.

‡‡‡‡Digestive Surgery Department, Sainte Marguerite Hospital, Marseille, France.

§§§§Urology Department, Le Bocage Hospital, Dijon, France.

¶¶¶¶Urology Department, Pellegrin Hospital, Bordeaux, France.

Reprints: Anne-Marie Leroi, MD, PhD, Service de Physiologie Digestive, Hôpital Charles Nicolle, 1 rue de Germont, 76031 Rouen Cedex, France. E-mail:

Supported by the French Ministry of Health.

Anne-Marie Leroi has analyzed the clinical data and has written the article. Francis Michot was an inspirator of the study with Anne-Marie Leroi and included patients. Xavier Lenne and Benoît Dervaux have performed medicoeconomic analyses. Each other author represents a center involved in this study and has included patients.

Anne-Marie Leroi and François Mion have relevant financial relationships with Medtronic as speaker for symposium organized by Medtronic.

Emmanuel Chartier-Kastler has the following financial relationship—Medtronic: Speaker and Investigator, Allergan: Consultant and Investigator, Ipsen: Investigator, Coloplast: Investigator, Astrazeneca: Investigator, and Astellas: Speaker.

Xavier Lenne, Brigitte Mauroy, Loïc Le Normand, Philippe Grise, Jean-Luc Faucheron, Yann Parc, Paul-Antoine Lehur, Henri Damon, Xavier Barth, Albert Leriche, Christian Saussine, Laurent Guy, François Haab, Laurent Bresler, Jean-Pierre Sarramon, Henri Bensadoun, Eric Rullier, Karem Slim, Igor Sielezneff, Eric Mourey, Philippe Ballanger, and Francis Michot have no financial disclosure or commercial sponsorship of the research described in the authors' manuscript.

© 2011 Lippincott Williams & Wilkins, Inc.