Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Evaluation of incontinence episodes using Bladder diary
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Control Group
Control group
Intervention: Pelvic floor muscle training (Procedure)
Treatment Group
Treatment with the investigational device - rPMS
Intervention: rPMS device (Device)
Outcomes
Primary Outcomes
Evaluation of incontinence episodes using Bladder diary
Time Frame: 13 months
Evaluation of change in incontinence episodes before and after the study treatment in both study groups.
Evaluation of quality of life improvement using the Pad Usage Questionnaire
Time Frame: 13 months
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 quality of life improvement using the UDI-6 questionnaire
Time Frame: 13 months
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 quality of life improvement using the ICIQ-LUTSqol questionnaire
Time Frame: 13 months
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 pelvic floor muscle strength
Time Frame: 13 months
Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.
Secondary Outcomes
- Subject Satisfaction evaluation(13 months)
- Safety evaluation(13 months)
- Therapy comfort evaluation(1 month)