OBJECTIVES: 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.
PATIENTS AND 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).
DISCUSSION AND CONCLUSION: 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).
Written by:
Lopès P, Rimbault F, Scheffler M, André C, Cappelletti MC, Marès P. Are you the author?
Service de gynécologie-obstétrique, hôpital mère-enfant, CHU de Nantes, 7, Quai-Moncousu, 44000 Nantes, France; Laboratoire Effik, immeuble Le Newton, 9-11, rue Jeanne-Braconnier, 92366 Meudon-La-Fôret cedex, France; 321, avenue Foch, 54000 Nancy, France; Hôpital Sainte-Anne, 1, rue Cabanis, 75014 Paris, France; Cabinet de kinésithérapie, 65, rue Francœur, 91170 Viry-Châtillon, France; Service de gynécologie-obstétrique, CHU Nîmes, 4, rue du Pr Robert-Debré, 30029 Nîmes, France.
Reference: Gynecol Obstet Fertil. 2014 Nov;42(11):779-86.
doi: 10.1016/j.gyobfe.2014.09.009
PubMed Abstract
PMID: 25444700
Article in French.