An interventional study of Magnetic stimulation and Sham Magnetic stimulation in Stress Urinary Incontinence, Urgency Urinary Incontinence and Mixed Urinary Incontinence, sponsored by Sunnybrook Health Sciences Centre. Enrolling by invitation at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
1) Non-pregnant adult female, not planning pregnancy during the duration of the study 2) primary symptoms of SUI, UUI, MUI (with SUI predominant symptoms) or MUI (with UUI predominant symptoms), as confirmed by history, focused evaluation for ≥3 months 3) objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc 4) Bladder capacity ≥200cc 5) Post void residual ≤100cc with Stage I or lower pelvic organ prolapse 6) For those with UUI symptoms: Post void residual ≤100cc with Stage I or lower pelvic organ prolapse 7) No concurrent or new planned treatment for UI during the treatment period and the 3 months following it 7) No known body metal from umbilicus to knees 8) Willing and able to comply with the protocol
Exclusion Criteria:
1) Patient is pregnant, lactating, or plans to become pregnant during the Study; or Patient is \<12 months post partum 2) Patient has other predominant type of UI (e.g. overflow UI, fistula) 3) Current chemo/radiotherapy; history of pelvic radiation; or pelvic surgery \< 3 months 4) Systemic diseases known to affect bladder function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury) 5) Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms 6) Current evaluation or treatment for chronic pelvic pain 7) Participation in another treatment intervention that might interfere with the results of this trial 8) Patient has a medical condition or disorder that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, and/or data). 9) Patient has ambulatory 24-hour pad test, where the increased pad weight is \< 3 grams. 10) Patient is non-ambulatory (ambulatory with assistive devices allowed) or unable to sit in a chair independently 12) Known body metal located from umbilicus to knees, or cardiac pacemaker 13) Previous magnetic stimulation therapy
Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 100%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.
Device: Magnetic stimulation
Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 5%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.
Device: Sham Magnetic stimulation
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
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
Plan to share: No
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Sunnybrook Health Sciences Centre