- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05952258
Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
Study Overview
Status
Conditions
Intervention / Treatment
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 stress urinary incontinence (SUI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of SUI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 158 patients. At the 3-month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Razia Sultana, MD, PhD
- Phone Number: 87776 416-480-6100
- Email: razia.sultana@sri.utoronto.ca
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- SunnyBrook Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1) 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.
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. 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
|
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.
|
The sham arm will receive up to 5% intensity at each treatment session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICIQ-SF (standardized, validated questionnaire)
Time Frame: 3 months post treatment
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The reporting by the patients of a "cure" at T3 (question #3 of the International Consultation on Incontinence Questionnaire, ICIQ-SF), we have chosen subjective cure as this is the ultimate goal for patients
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3 months post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UDI-6
Time Frame: 3, 6, 12 and 24 months post treatment
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(standardized, validated questionnaire)
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3, 6, 12 and 24 months post treatment
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IIQ-7
Time Frame: 3, 6, 12 and 24 months post treatment
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(standardized, validated questionnaire)
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3, 6, 12 and 24 months post treatment
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ICIQ-LUTS-qol
Time Frame: 3, 6, 12 and 24 months post treatment
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(standardized, validated questionnaire)
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3, 6, 12 and 24 months post treatment
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PGI-I
Time Frame: 3, 6, 12 and 24 months post treatment
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(standardized, validated questionnaire)
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3, 6, 12 and 24 months post treatment
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PISQ-12
Time Frame: 3, 6, 12 and 24 months post treatment
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(standardized, validated questionnaire)
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3, 6, 12 and 24 months post treatment
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24 hour pad test
Time Frame: 3 and 12 months
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an objective measure of incontinence and its severity
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3 and 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: P Lee, MD, Sunnybrook Health Sciences Centre,, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- 5819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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