Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

NCT ID: NCT05952258

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-07-31

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Magnetic stimulation

Intervention Type: DEVICE

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 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.

Group Type: PLACEBO_COMPARATOR

Sham Magnetic stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham Magnetic stimulation

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

P Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre,, University of Toronto

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

5819

Identifier Type: -

Identifier Source: org_study_id