Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence

In brief

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

Key facts

Study ID

NCT05952258

Run by

Sunnybrook Health Sciences Centre

People needed

158

Starts

2023-09-01

Expected to finish

2028-07-31

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Non-pregnant adult female, not planning pregnancy during the duration of the study 2) Stress urinary incontinence (SUI), 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) No concurrent or new planned treatment for SUI 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.

You may not qualify if…

• 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. Urgency UI, 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

Where it is running

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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