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Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magnetic stimulation
Sham Magnetic stimulation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Electromagnetic stimulation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnetic stimulation therapy

Sham therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ICIQ-SF (standardized, validated questionnaire)
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

UDI-6
(standardized, validated questionnaire)
IIQ-7
(standardized, validated questionnaire)
ICIQ-LUTS-qol
(standardized, validated questionnaire)
PGI-I
(standardized, validated questionnaire)
PISQ-12
(standardized, validated questionnaire)
24 hour pad test
an objective measure of incontinence and its severity

Full Information

First Posted
July 11, 2023
Last Updated
October 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT05952258
Brief Title
Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
Official Title
Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Electromagnetic stimulation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded RCT
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic stimulation therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic stimulation
Intervention Description
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
Intervention Name(s)
Sham Magnetic stimulation
Intervention Description
The sham arm will receive up to 5% intensity at each treatment session
Primary Outcome Measure Information:
Title
ICIQ-SF (standardized, validated questionnaire)
Description
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
Time Frame
3 months post treatment
Secondary Outcome Measure Information:
Title
UDI-6
Description
(standardized, validated questionnaire)
Time Frame
3, 6, 12 and 24 months post treatment
Title
IIQ-7
Description
(standardized, validated questionnaire)
Time Frame
3, 6, 12 and 24 months post treatment
Title
ICIQ-LUTS-qol
Description
(standardized, validated questionnaire)
Time Frame
3, 6, 12 and 24 months post treatment
Title
PGI-I
Description
(standardized, validated questionnaire)
Time Frame
3, 6, 12 and 24 months post treatment
Title
PISQ-12
Description
(standardized, validated questionnaire)
Time Frame
3, 6, 12 and 24 months post treatment
Title
24 hour pad test
Description
an objective measure of incontinence and its severity
Time Frame
3 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Razia Sultana, MD, PhD
Phone
416-480-6100
Ext
87776
Email
razia.sultana@sri.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P Lee, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre,, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Razia Sultana, MD, PhD
Phone
416-480-6100
Ext
87776
Email
razia.sultana@sri.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Patricia Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

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