Igor But1. 1. Department of Gynecology, Maribor Teaching Hospital, Maribor, Slovenia.
Abstract
OBJECTIVES: To determine the efficacy and safety of functional magnetic stimulation (FMS) produced by the Pulsegen device compared with placebo in the treatment of women with urinary incontinence. METHODS:Fifty-five women with urinary incontinence were randomly assigned to the active FMS group (30 patients) or the placebo group (22 patients). Each patient in the active group received a Pulsegen device, which produced a pulsating magnetic field of B = 10microT intensity and a frequency of 10 Hz. Patients were asked to wear the Pulsegen device day and night for 2 months. Clinical and urodynamic data were collected before and after FMS and analyzed using nonparametric statistics. RESULTS: Compared with the placebo, the number of pads used was significantly lower (P = 0.0031) after FMS, as was the pad weight (P = 0.014). In patients from the active group, a significant improvement in the power of the pelvic floor muscle contractions (P = 0.0071), as well as in the duration of the pelvic floor muscle contractions (P = 0.038), was observed. After FMS, a 56.3% improvement in urinary incontinence symptoms was reported by patients in the active group, a significantly greater difference (P = 0.00012) compared with the reported 26.3% improvement in symptoms in the placebo group. CONCLUSIONS: We believe that FMS represents a new method in the conservative treatment of urinary incontinence. Magnetic stimulation with the Pulsegen device is efficient and safe. It can be used at home and, because of its small size, wearing the device is not annoying for patients.
RCT Entities:
OBJECTIVES: To determine the efficacy and safety of functional magnetic stimulation (FMS) produced by the Pulsegen device compared with placebo in the treatment of women with urinary incontinence. METHODS: Fifty-five women with urinary incontinence were randomly assigned to the active FMS group (30 patients) or the placebo group (22 patients). Each patient in the active group received a Pulsegen device, which produced a pulsating magnetic field of B = 10 microT intensity and a frequency of 10 Hz. Patients were asked to wear the Pulsegen device day and night for 2 months. Clinical and urodynamic data were collected before and after FMS and analyzed using nonparametric statistics. RESULTS: Compared with the placebo, the number of pads used was significantly lower (P = 0.0031) after FMS, as was the pad weight (P = 0.014). In patients from the active group, a significant improvement in the power of the pelvic floor muscle contractions (P = 0.0071), as well as in the duration of the pelvic floor muscle contractions (P = 0.038), was observed. After FMS, a 56.3% improvement in urinary incontinence symptoms was reported by patients in the active group, a significantly greater difference (P = 0.00012) compared with the reported 26.3% improvement in symptoms in the placebo group. CONCLUSIONS: We believe that FMS represents a new method in the conservative treatment of urinary incontinence. Magnetic stimulation with the Pulsegen device is efficient and safe. It can be used at home and, because of its small size, wearing the device is not annoying for patients.