Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Recruitment & Eligibility

Inclusion Criteria

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

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 & Design

Arm && Interventions

Group	Intervention	Description
Magnetic stimulation therapy	Magnetic stimulation	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.
Sham therapy	Sham Magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
UDI-6	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
IIQ-7	3, 6, 12 and 24 months post treatment	(standardized, validated questionnaire)
PISQ-12	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)
PGI-I	3, 6, 12 and 24 months post treatment	(standardized, validated questionnaire)

Recruitment & Eligibility