Denise Cuevas Pérez1,2,3, Carolina Walker Chao4, Lucía Llanos Jiménez5, Ignacio Mahíllo Fernández6, Ana Isabel de la Llave Rincón7. 1. Department of Physical Therapy, Occupational Therapy, Rehabilitation, and Physical Medicine, Universidad Rey Juan Carlos, Avenida de Atenas s/n, 28922, Alcorcón, Madrid, Spain. eirhe@hotmail.com. 2. Hospital General de Villalba (HGV), Carretera de Alpedrete a Moralzarzal M-608 km 41, 28400, Collado Villalba, Madrid, Spain. eirhe@hotmail.com. 3. Hospital Universitario Rey Juan Carlos (HURJC), Calle Gladiolo s/n, 28933, Móstoles, Madrid, Spain. eirhe@hotmail.com. 4. Hospital Universitario Quironsalud Madrid, Calle Diego de Velazquez, 1, Pozuelo de Alarcon, Madrid, 28223, Spain. 5. Clinical Research Unit, Health Research Institute-Jimenez Diaz Foundation, University Hospital (IIS-FJD), Madrid, Spain. 6. Biostatistics and Epidemiology Unit, Health Research Institute-Jimenez Diaz Foundation, University Hospital (IIS-FJD), Madrid, Spain. 7. Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Madrid, Spain.
Abstract
INTRODUCTION AND HYPOTHESIS: Lower urinary tract symptoms (LUTS) affect up to 80% of patients with multiple sclerosis (MS). The present randomized, open-label, clinical trial examines the effectiveness, as a conservative treatment for LUTS, of a physiotherapist-guided pelvic floor muscle training (PFMT) program adapted for patients with relapsing-remitting multiple sclerosis (RRMS) and urinary incontinence (UI). METHODS:Forty-eight patients with RRMS were randomly assigned to a 12-week PFMT program with or without physiotherapist guidance. The primary endpoint was the reduction in urinary leakages after 12 weeks of following the program. The secondary variables assessed were quality of life (QoL), UI severity, LUTS, and treatment adherence. RESULTS:Forty patients completed the program. No significant differences in baseline characteristics were seen between the two treatment groups. At 12 weeks, both groups reported a significantly reduced number of leakages compared with baseline (P < 0.001), with no significant differences seen between groups (P = 0.210). In the physiotherapist-guided group, significant differences were found in QoL, UI severity, and LUTS between baseline and 12 weeks, for both male and female subjects. No significant differences in adherence were seen between the two treatment groups. CONCLUSIONS: No difference in leakage reduction was seen between physiotherapist-guided and unguided PFMT. However, the physiotherapist-guided program was associated with improvements in UI severity, QoL, and LUTS in women and men. The guided PFMT group also showed a trend towards better adherence to treatment. CLINICAL TRIAL REGISTRATION: No. NCT03000647; Title: "Guided Versus Non-Guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis."
RCT Entities:
INTRODUCTION AND HYPOTHESIS: Lower urinary tract symptoms (LUTS) affect up to 80% of patients with multiple sclerosis (MS). The present randomized, open-label, clinical trial examines the effectiveness, as a conservative treatment for LUTS, of a physiotherapist-guided pelvic floor muscle training (PFMT) program adapted for patients with relapsing-remitting multiple sclerosis (RRMS) and urinary incontinence (UI). METHODS: Forty-eight patients with RRMS were randomly assigned to a 12-week PFMT program with or without physiotherapist guidance. The primary endpoint was the reduction in urinary leakages after 12 weeks of following the program. The secondary variables assessed were quality of life (QoL), UI severity, LUTS, and treatment adherence. RESULTS: Forty patients completed the program. No significant differences in baseline characteristics were seen between the two treatment groups. At 12 weeks, both groups reported a significantly reduced number of leakages compared with baseline (P < 0.001), with no significant differences seen between groups (P = 0.210). In the physiotherapist-guided group, significant differences were found in QoL, UI severity, and LUTS between baseline and 12 weeks, for both male and female subjects. No significant differences in adherence were seen between the two treatment groups. CONCLUSIONS: No difference in leakage reduction was seen between physiotherapist-guided and unguided PFMT. However, the physiotherapist-guided program was associated with improvements in UI severity, QoL, and LUTS in women and men. The guided PFMT group also showed a trend towards better adherence to treatment. CLINICAL TRIAL REGISTRATION: No. NCT03000647; Title: "Guided Versus Non-Guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis."
Authors: Bernard T Haylen; Dirk de Ridder; Robert M Freeman; Steven E Swift; Bary Berghmans; Joseph Lee; Ash Monga; Eckhard Petri; Diaa E Rizk; Peter K Sand; Gabriel N Schaer Journal: Neurourol Urodyn Date: 2010 Impact factor: 2.696