title: [Multicentric prospective randomized study evaluating the interest of intravaginal electro-stimulation at home for urinary incontinence after prior perineal reeducation. Interim analysis].
abstract: OBJECTIVE
  Perineal reeducation of stress urinary incontinence is beneficial in 80% of cases. However, patients have to perform self-retraining exercises of the perineal muscles at home, in order to maintain the benefit of the physiotherapy. The aim of this study is to assess the benefit of GYNEFFIK(®), a perineal electro-stimulator, during this home-care phase.
  
  
  METHODS
  Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI) that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK(®) electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained (defined as non-worsening ICIQ and Ditrovie scales' score).
  
  
  RESULTS
  According to the protocol, an interim analysis was performed on 95 patients (i.e. almost half of the expected sample size) who had had at least one evaluation under treatment, among which 44 patients had finished the study. The therapeutic benefit of the initial perineal reeducation was maintained in 87.8% of the GYNEFFIK(®) patient group, while it was maintained in 52.2% (P=0.0001) in the usual care group (i.e. who did not use electro-stimulation).
  
  
  CONCLUSIONS
  Likewise, patient had a more favorable subjective impression when using GYNEFFIK(®) (83.7% versus 60.0% in the usual care group) as they felt that they improved during the study. In the GYNEFFIK(®) group, no increase in symptoms was reported, whereas almost one out of five patients in the usual care group felt that their condition had worsened.
authors.affiliation: Service de gynécologie-obstétrique, hôpital Mère et Enfants, hôpital de Nantes, CHU de Nantes, 38, boulevard Jean-Monnet, 44000 Nantes, France. Electronic address: patrice.lopes@chu-nantes.fr.
authors.forename: P
authors.initials: P
authors.lastname: Lopès
authors.affiliation: Laboratoire EFFIK, 92366 Meudon-la-Forêt, France.
authors.forename: R
authors.initials: R
authors.lastname: Levy-Toledano
authors.affiliation: Vivactis-M2 Research, 92200 Neuilly-sur-Seine, France.
authors.forename: P
authors.initials: P
authors.lastname: Chiarelli
authors.affiliation: Laboratoire EFFIK, 92366 Meudon-la-Forêt, France.
authors.forename: F
authors.initials: F
authors.lastname: Rimbault
authors.affiliation: Service de gynécologie-obstétrique, hôpital de Nîmes, place du Pr-R.-Debré, 30029 Nîmes cedex 9, France.
authors.forename: P
authors.initials: P
authors.lastname: Marès
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D010502:Perineum / Q000503:physiopathology*; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000628:therapy*; D014621:Vagina
keywords: Dispositif médical; Femmes; Incontinence urinaire; Intravaginal electro-stimulation at home; Medical device; Quality of life; Qualité de vie; Urinary incontinence; Women; Électrostimulation vaginale à domicile