Stress Urinary IncontinenceNCT05952258
Magnetic Stimulation as a Treatment for Female Urinary Incontinence
A study testing Magnetic stimulation in people with Stress Urinary Incontinence and Urgency Urinary Incontinence, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urgency Urinary Incontinence, Mixed Urinary Incontinence
- What is being tested?
- Magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 31 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Magnetic stimulation, Sham Magnetic stimulation
- Keywords
- Electromagnetic stimulation therapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stimulationDevice
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.
Sham Magnetic stimulationDevice
The sham arm will receive up to 5% intensity at each treatment session
| Study group | Role | What they receive |
|---|---|---|
| Magnetic stimulation therapy | Active comparator | 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. Receives: Device: Magnetic stimulation |
| Sham therapy | Placebo comparator | 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. Receives: Device: Sham Magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post treatment
Secondary outcomes (6)
UDI-6
(standardized, validated questionnaire)
Measured: 3, 6, 12 and 24 months post treatment
IIQ-7
(standardized, validated questionnaire)
Measured: 3, 6, 12 and 24 months post treatment
ICIQ-LUTS-qol
(standardized, validated questionnaire)
Measured: 3, 6, 12 and 24 months post treatment
PGI-I
(standardized, validated questionnaire)
Measured: 3, 6, 12 and 24 months post treatment
PISQ-12
(standardized, validated questionnaire)
Measured: 3, 6, 12 and 24 months post treatment
24 hour pad test
an objective measure of incontinence and its severity
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Sep 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
- Responsible party
- Sponsor
- Investigators
- P Lee, MD, Principal investigator, Sunnybrook Health Sciences Centre,, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952258
- Sponsor's protocol ID
- 5819
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No