Clinical trial NCT05952258: Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
Official title: Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Electromagnetic stimulation therapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
First posted: 2023-07-19
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded RCT
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ICIQ-SF (standardized, validated questionnaire)
timeFrame: 3 months post treatment
Secondary outcomes:
measure: UDI-6
timeFrame: 3, 6, 12 and 24 months post treatment
measure: IIQ-7
timeFrame: 3, 6, 12 and 24 months post treatment
measure: ICIQ-LUTS-qol
timeFrame: 3, 6, 12 and 24 months post treatment
measure: PGI-I
timeFrame: 3, 6, 12 and 24 months post treatment
measure: PISQ-12
timeFrame: 3, 6, 12 and 24 months post treatment
measure: 24 hour pad test
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre,, University of Toronto
name: P Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: