The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with urinary incontinence.
A double-blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm will be conducted; followed by an open label trial at 3 months for any sham treatment arm participants who do not meet treatment success. The primary goal is to compare the subjective success rates for the resolution of female urinary incontinence (UI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of UI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 220 patients. At the 3-month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
The magnetic stimulation to the pelvic floor muscle will be provided by the Emsella® chair: which will be activated for 28 minutes at each treatment session. The treatment arm will receive up to 100% intensity at each treatment session.
The sham arm will receive up to 5% intensity at each treatment session
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
ICIQ-SF (standardized, validated questionnaire)
The reporting by the patients of a "cure" of stress urinary incontinence at T3 (question #3 of the International Consultation on Incontinence Questionnaire, ICIQ-SF). For those with Urgency urinary incontinence (UUI) we have chosen subjective improvement in symptoms of UI as indicated by the change in ICIQ-SF total score.
Time frame: 3 months post treatment
UDI-6
(standardized, validated questionnaire)
Time frame: 3, 6, 12 and 24 months post treatment
IIQ-7
(standardized, validated questionnaire)
Time frame: 3, 6, 12 and 24 months post treatment
ICIQ-LUTS-qol
(standardized, validated questionnaire)
Time frame: 3, 6, 12 and 24 months post treatment
PGI-I
(standardized, validated questionnaire)
Time frame: 3, 6, 12 and 24 months post treatment
PISQ-12
(standardized, validated questionnaire)
Time frame: 3, 6, 12 and 24 months post treatment
24 hour pad test
an objective measure of incontinence and its severity
Time frame: 3 and 12 months
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