Back to resultsrPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rPMS device
Pelvic floor muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Female aged 25-70 years
- Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
- Voluntarily signed informed consent form
- Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
- Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study
Exclusion Criteria:
- Use of Botox® in the bladder or pelvic muscles in the last year
- Use of Interstim® or similar device for the treatment of UI
- Suffers from other types of urinary incontinence other than SUI, UUI, MUI
- Pelvic organ prolapse grade 2 and higher
- Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
- 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
- Any disorders that the Investigator deems would interfere with study endpoints or subject safety
Sites / Locations
- Boston Urogyn
- Center for Urogynecology and Reconstructive Surgery
- The Female Pelvic Health Center
- The Female Pelvic Medicine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Control Group
Arm Description
Treatment with the investigational device - rPMS
Control group
Outcomes
Primary Outcome Measures
Evaluation of quality of life improvement using the UDI-6 questionnaire
Evaluation of change in UDI-6 score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.
Evaluation of incontinence episodes using Bladder diary
Evaluation of change in incontinence episodes before and after the study treatment in both study groups.
Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire
Evaluation of change in ICIQ-LUTSqol score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.
Evaluation of quality of life improvement using the Pad Usage Questionnaire
Evaluation of change in Pad Usage Questionnaire before and after the study treatment in both study groups. Decrease in number of used pads will be considered as an improvement.
Evaluation of pelvic floor muscle strength
Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.
Secondary Outcome Measures
Subject Satisfaction evaluation
Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment.
Therapy comfort evaluation
Evaluation of therapy comfort after each treatment or training session using the questionnaire.
Safety evaluation
Incidence of adverse events (AE) associated with study device will be followed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03969368
Brief Title
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Official Title
Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 23, 2021 (Actual)
Study Completion Date
June 23, 2022 (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
This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment with the investigational device - rPMS
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
rPMS device
Intervention Description
Pelvic floor muscle contractions will be induced by the rPMS device.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
Control group will undergo a pelvic floor muscle training
Primary Outcome Measure Information:
Title
Evaluation of quality of life improvement using the UDI-6 questionnaire
Description
Evaluation of change in UDI-6 score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.
Time Frame
13 months
Title
Evaluation of incontinence episodes using Bladder diary
Description
Evaluation of change in incontinence episodes before and after the study treatment in both study groups.
Time Frame
13 months
Title
Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire
Description
Evaluation of change in ICIQ-LUTSqol score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.
Time Frame
13 months
Title
Evaluation of quality of life improvement using the Pad Usage Questionnaire
Description
Evaluation of change in Pad Usage Questionnaire before and after the study treatment in both study groups. Decrease in number of used pads will be considered as an improvement.
Time Frame
13 months
Title
Evaluation of pelvic floor muscle strength
Description
Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Subject Satisfaction evaluation
Description
Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment.
Time Frame
13 months
Title
Therapy comfort evaluation
Description
Evaluation of therapy comfort after each treatment or training session using the questionnaire.
Time Frame
1 month
Title
Safety evaluation
Description
Incidence of adverse events (AE) associated with study device will be followed.
Time Frame
13 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female aged 25-70 years
Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
Voluntarily signed informed consent form
Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study
Exclusion Criteria:
Use of Botox® in the bladder or pelvic muscles in the last year
Use of Interstim® or similar device for the treatment of UI
Suffers from other types of urinary incontinence other than SUI, UUI, MUI
Pelvic organ prolapse grade 2 and higher
Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
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
Any disorders that the Investigator deems would interfere with study endpoints or subject safety
Facility Information:
Facility Name
Boston Urogyn
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Center for Urogynecology and Reconstructive Surgery
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
The Female Pelvic Health Center
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
The Female Pelvic Medicine Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
12. IPD Sharing Statement
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rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
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