title: [Multicentric prospective randomized and controlled study assessing effectiveness of intravaginal electrostimulation at home compared to usual care in female patients with urinary incontinence and prior perineal reeducation].
abstract: OBJECTIVE
  In order to maintain the benefits of perineal reeducation, patients with stress urinary incontinence need to perform self-retraining exercises of the perineal muscles at home. The aim of this randomized prospective multicentric study is to assess the effectiveness of GYNEFFIK(®), a perineal electrostimulator, during this home-care phase.
  
  
  METHODS
  Two parallel groups of women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), improved by physiotherapy, have followed a self-reeducation program, either with electrostimulation sessions (GYNEFFIK(®) or home perineal electrostimulation [HPES] arm) or with usual care (UC) only, without electrostimulation. The comparison of the two groups was based on the rate of women in which the benefit of the initial perineal reeducation was maintained (defined as the ICIQ and Ditrovie scales' score not worsening) at 2, 4 and 6 months.
  
  
  RESULTS
  A total of 161 patients were analyzed (76 in the HPES arm and 85 in the UC arm). The therapeutic benefit of the initial perineal reeducation at the last available measure (6 months for a wide majority of patients) was maintained in 81.6% in the HPES arm versus 62.4% in the UC arm (P=0.007). This significant difference reflects a significant improvement both in clinical symptomatology and in quality of life. ICIQ score was improved in 44% of patients of HPES arm while it was improved in 14% of patients of UC arm (P<0.001) and daily number of urine leakage decreased of 1.2 leakage in the HPES arm versus 0.1 leakage in UC arm (P<0.05). Likewise, improvement of quality of life was superior in the HPES arm (48% improvement of Ditrovie score versus 19% in the UC group ; P<0.05).
  
  
  CONCLUSIONS
  Investigator global impression was more favorable in the HPES arm (clinical improvement in 83% of patients versus 68% in the UC arm). At the last measure (i.e. endpoint), the benefit of initial physiotherapy was considered maintained or improved in all patients of the HPES arm while it was reported as worsened in 16.5% of the UC group. Using GYNEFFIK(®) favorably impacts quality of life, particularly physical activity and vitality and decreases emotional consequences of UI (i.e. anxiety and depression score as assessed by HAD scale).
authors.affiliation: Service de gynécologie-obstétrique, hôpital mère-enfant, CHU de Nantes, 7, Quai-Moncousu, 44000 Nantes, France. Electronic address: patrice.lopes@chu-nantes.fr.
authors.forename: P
authors.initials: P
authors.lastname: Lopès
authors.affiliation: Laboratoire Effik, immeuble Le Newton, 9-11, rue Jeanne-Braconnier, 92366 Meudon-La-Fôret cedex, France.
authors.forename: F
authors.initials: F
authors.lastname: Rimbault
authors.affiliation: 21, avenue Foch, 54000 Nancy, France.
authors.forename: M
authors.initials: M
authors.lastname: Scheffler
authors.affiliation: Hôpital Sainte-Anne, 1, rue Cabanis, 75014 Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: André
authors.affiliation: Cabinet de kinésithérapie, 65, rue Francœur, 91170 Viry-Châtillon, France.
authors.forename: M-C
authors.initials: MC
authors.lastname: Cappelletti
authors.affiliation: Service de gynécologie-obstétrique, CHU Nîmes, 4, rue du Pr Robert-Debré, 30029 Nîmes, France.
authors.forename: P
authors.initials: P
authors.lastname: Marès
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010502:Perineum; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000523:psychology / Q000628:therapy*; D014550:Urinary Incontinence, Stress / Q000628:therapy; D014621:Vagina
keywords: Dispositif médical; Electrostimulation vaginale à domicile; Femmes; Incontinence urinaire; Intravaginal electrostimulation at home; Medical device; Quality of life; Qualité de vie; Urinary incontinence; Women