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Behavioural Intervention

Magnetic Stimulation for Stress Urinary Incontinence

N/A

Waitlist Available

Led By P Lee, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No concurrent or new planned treatment for SUI during the treatment period and the 3 months following it

Non-pregnant adult female, not planning pregnancy during the duration of the study

Must not have

Patient has ambulatory 24-hour pad test, where the increased pad weight is < 3 grams

Current evaluation or treatment for chronic pelvic pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12 and 24 months post treatment

Summary

This trial tests an electric therapy to help women with leaking urine when they sneeze, cough, or exercise.

Who is the study for?

This trial is for adult females with stress urinary incontinence, who are not pregnant or planning pregnancy, without metal implants from umbilicus to knees. Participants should have no recent pelvic treatments and be able to follow the study protocol. Exclusions include those on current chemo/radiotherapy, with systemic diseases affecting bladder function, or other types of urinary incontinence.

What is being tested?

The trial tests if electromagnetic stimulation can help women with stress urinary incontinence by strengthening their pelvic floor muscles. It compares real magnetic stimulation treatment against a sham (fake) procedure to see if there's an actual benefit.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site or muscle fatigue due to the stimulation process. Since it's non-invasive, serious side effects are unlikely but could involve skin irritation or temporary pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not planning any treatment for stress urinary incontinence soon.

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I am not pregnant and do not plan to become pregnant during the study.

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I can empty my bladder well and have minimal pelvic organ drop.

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My bladder can hold at least 200cc of urine.

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I have seen urine leak when I cough or strain with a partly full bladder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pad weight increase is less than 3 grams in a 24-hour test.

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I am currently being treated for chronic pelvic pain.

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I cannot walk on my own without help or sit up by myself.

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I have a condition like Parkinson's or MS that affects bladder control.

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I have undergone magnetic stimulation therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12 and 24 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12 and 24 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 and 24 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ICIQ-SF (standardized, validated questionnaire)

Secondary study objectives

24 hour pad test

ICIQ-LUTS-qol

IIQ-7

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Magnetic stimulation therapyActive Control1 Intervention

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.

Group II: Sham therapyPlacebo Group1 Intervention

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.

0 / 10Eligibility criteria met