Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT05952258
• Recruitment Status: Enrolling by invitation
• First Posted: July 19, 2023
• Last Update Posted: February 15, 2024
• Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
• Information provided by (Responsible Party): Sunnybrook Health Sciences Centre

Study Description

Brief 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 stress urinary incontinence.

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Device: Magnetic stimulation; Device: Sham Magnetic stimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blinded RCT
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
• Actual Study Start Date: September 1, 2023
• Estimated Primary Completion Date: July 31, 2025
• Estimated Study Completion Date: July 31, 2026

Arms and Interventions

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.	Device: Magnetic 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.
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; The sham arm will receive up to 5% intensity at each treatment session

Outcome Measures

Primary Outcome Measures :

1. ICIQ-SF (standardized, validated questionnaire) [ Time Frame: 3 months post treatment ]
   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

Secondary Outcome Measures :

1. UDI-6 [ Time Frame: 3, 6, 12 and 24 months post treatment ]
   (standardized, validated questionnaire)
2. IIQ-7 [ Time Frame: 3, 6, 12 and 24 months post treatment ]
   (standardized, validated questionnaire)
3. ICIQ-LUTS-qol [ Time Frame: 3, 6, 12 and 24 months post treatment ]
   (standardized, validated questionnaire)
4. PGI-I [ Time Frame: 3, 6, 12 and 24 months post treatment ]
   (standardized, validated questionnaire)
5. PISQ-12 [ Time Frame: 3, 6, 12 and 24 months post treatment ]
   (standardized, validated questionnaire)
6. 24 hour pad test [ Time Frame: 3 and 12 months ]
   an objective measure of incontinence and its severity

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

Investigators

• Principal Investigator: P Lee, MD; Sunnybrook Health Sciences Centre,, University of Toronto

More Information

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT05952258
• Other Study ID Numbers: 5819
• First Posted: July 19, 2023
• Last Update Posted: February 15, 2024
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sunnybrook Health Sciences Centre:

Electromagnetic stimulation therapy

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders