ClinicalTrials.gg
Enrolling by invitationNCT05952258Updated Aug 27, 2026

Magnetic Stimulation as a Treatment for Female Urinary Incontinence

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

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 47 studies in Urinary Incontinence, Stress with a site in Canada — 6 open to participants now, 10 under way, 1 of them phase 3. Urinary Incontinence, Stress · Canada.

Planned enrollment
10th of 40
220 · median 86
Started
2023
the only one that year
No phase
28 of 47
2 open now
Registered
41st of 47
by date
Lead sponsor
4 of 47
Sunnybrook Health Sciences Centre

Among the 47 studies in Urinary Incontinence, Stress with a site in Canada, this one is the 10th largest by planned enrollment of the 40 interventional ones that give a count, is the only one that started in 2023, is one of 28 with no phase, and was the 41st registered.

Urinary Incontinence, Stress

653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.

Browse Urinary Incontinence, Stress studies →

Open to participants now

6 of the 47 studies in Urinary Incontinence, Stress with a site in Canada are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Stress Urinary Incontinence
  • Urgency Urinary Incontinence
  • Mixed Urinary Incontinence

Keywords

  • Electromagnetic stimulation therapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    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

  • Placebo comparator
    Sham 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 5%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.

    Device: Sham Magnetic stimulation

Interventions

  • DeviceMagnetic 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.

  • DeviceSham Magnetic stimulation

    The sham arm will receive up to 5% intensity at each treatment session

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. UDI-6

    (standardized, validated questionnaire)

    Time frame: 3, 6, 12 and 24 months post treatment

  2. IIQ-7

    (standardized, validated questionnaire)

    Time frame: 3, 6, 12 and 24 months post treatment

  3. ICIQ-LUTS-qol

    (standardized, validated questionnaire)

    Time frame: 3, 6, 12 and 24 months post treatment

  4. PGI-I

    (standardized, validated questionnaire)

    Time frame: 3, 6, 12 and 24 months post treatment

  5. PISQ-12

    (standardized, validated questionnaire)

    Time frame: 3, 6, 12 and 24 months post treatment

  6. 24 hour pad test

    an objective measure of incontinence and its severity

    Time frame: 3 and 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jul 2027, 46 months after the start.

Of 226 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 46 months is above that.

Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2023
First posted
Jul 19, 2023
StartActual
Sep 1, 2023
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2028
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05952258
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
Responsible party
Sponsor
First posted
Jul 19, 2023
Start date
Sep 1, 2023
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

P Lee, MD
principal investigator · Sunnybrook Health Sciences Centre,, University of Toronto

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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