rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: rPMS device
* Procedure: Pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Treatment with the investigational device - rPMS | Device: rPMS device<br>* Pelvic floor muscle contractions will be induced by the rPMS device.<br>|
| Active Comparator: Control Group<br>Control group | Procedure: Pelvic floor muscle training<br>* Control group will undergo a pelvic floor muscle training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 13 months | 
| Evaluation of incontinence episodes using Bladder diary | Evaluation of change in incontinence episodes before and after the study treatment in both study groups. | 13 months | 
| 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. | 13 months | 
| 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. | 13 months | 
| Evaluation of pelvic floor muscle strength | Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups. | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 13 months | 
| Therapy comfort evaluation | Evaluation of therapy comfort after each treatment or training session using the questionnaire. | 1 month | 
| Safety evaluation | Incidence of adverse events (AE) associated with study device will be followed. | 13 months |