Back to resultsEfficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rPMS device
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Age between 21 and 65 years
- Voluntarily signed informed consent form
- Suffers from UI
- Sexually active
- FSFI Questionnaire score ≤ 26.55 points
Exclusion Criteria:
- Suffers from other types of urinary incontinence other than SUI, UUI, MUI
- Currently lactating
- Cardiac pacemakers
- Implanted defibrillators and/or neurostimulators
- Electronic implants
- Metal implants, including copper IUD
- Drug pumps
- Hemorrhagic conditions
- Anticoagulation therapy
- Fever
- Pregnancy
- Following recent surgical procedures when muscle contraction may disrupt the healing process
- Application over areas of the skin which lack normal sensation
Sites / Locations
- Julene Samuels
- Joseph Berenholz
- Gynecological Solutions
- Southern Urogynecology
- Hillcroft Medical Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Treatment with the investigational device - rPMS
Outcomes
Primary Outcome Measures
Evaluation of quality of life improvement using the ICIQ-UI questionnaire
Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.
Evaluation of quality of life improvement using the FSFI questionnaire
Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.
Evaluation of quality of life improvement using the PISQ-12 questionnaire
Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement.
Secondary Outcome Measures
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
Incidence of adverse events (AE) associated with study device will be followed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03942484
Brief Title
Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
Official Title
Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
October 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment with the investigational device - rPMS
Intervention Type
Device
Intervention Name(s)
rPMS device
Intervention Description
Pelvic floor muscle contractions will be induced by the device.
Primary Outcome Measure Information:
Title
Evaluation of quality of life improvement using the ICIQ-UI questionnaire
Description
Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.
Time Frame
18 months
Title
Evaluation of quality of life improvement using the FSFI questionnaire
Description
Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.
Time Frame
18 months
Title
Evaluation of quality of life improvement using the PISQ-12 questionnaire
Description
Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
Description
Incidence of adverse events (AE) associated with study device will be followed.
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 21 and 65 years
Voluntarily signed informed consent form
Suffers from UI
Sexually active
FSFI Questionnaire score ≤ 26.55 points
Exclusion Criteria:
Suffers from other types of urinary incontinence other than SUI, UUI, MUI
Currently lactating
Cardiac pacemakers
Implanted defibrillators and/or neurostimulators
Electronic implants
Metal implants, including copper IUD
Drug pumps
Hemorrhagic conditions
Anticoagulation therapy
Fever
Pregnancy
Following recent surgical procedures when muscle contraction may disrupt the healing process
Application over areas of the skin which lack normal sensation
Facility Information:
Facility Name
Julene Samuels
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Joseph Berenholz
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Gynecological Solutions
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Southern Urogynecology
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Hillcroft Medical Clinic
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
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