Pelvic static magnetic stimulation to control urinary incontinence in older women: A randomized controlled trial

Objectives To determine the efficacy of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence for six or more months.

Subjects and Methods A single blinded randomised, placebo-controlled, parallel-group trial. Subjects were excluded if they had an implanted electronic device, if they had experienced a symptomatic urinary tract infection, or had commenced pharmacotherapy for the same in the previous four weeks or if they were booked for pelvic floor or gynaecological surgery within the next three months. Once written consent was obtained subjects were randomly assigned to the active SMS group (n=50) or the placebo group (n=51). Treatment was an undergarment incorporating 15 static magnets of 800–1200 Gauss, anterior, posterior and inferior to the pelvis for at least 12 hours a day for three months. Placebo was the same protocol with inert metal disks replacing the magnets. Primary outcome measure was cessation of incontinence as measured by a 24 hour pad test. Secondary outcomes were frequency and severity of symptoms as measured by the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF), the Incontinence Severity Index, Bothersomeness scale and a 24 hour Bladder Diary. Data were collected at baseline and 12 weeks later.

Results There were no statistically significant differences between groups in any of the outcome measures from baseline to 12 weeks. Initial evidence of subjective improvement in the treatment group compared to the placebo group, was not sustained with sensitivity analysis.

Conclusion This study found no evidence that static magnets cure or decrease the symptoms of urinary incontinence. Additional work into the basic physics of the product and garment design is recommended prior to further clinical trials research.