Stress Urinary Incontinence
Conditions
Keywords
Electromagnetic stimulation therapy
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.
Interventions
DEVICEMagnetic 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.
The sham arm will receive up to 5% intensity at each treatment session
Sponsors
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double blinded RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICIQ-SF (standardized, validated questionnaire) | 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
| Measure | Time frame | Description |
|---|---|---|
| IIQ-7 | 3, 6, 12 and 24 months post treatment | (standardized, validated questionnaire) |
| ICIQ-LUTS-qol | 3, 6, 12 and 24 months post treatment | (standardized, validated questionnaire) |
| UDI-6 | 3, 6, 12 and 24 months post treatment | (standardized, validated questionnaire) |
| PISQ-12 | 3, 6, 12 and 24 months post treatment | (standardized, validated questionnaire) |
| 24 hour pad test | 3 and 12 months | an objective measure of incontinence and its severity |
| PGI-I | 3, 6, 12 and 24 months post treatment | (standardized, validated questionnaire) |
Countries
Canada
Outcome results
None listed