Urinary Incontinence
Conditions
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.
Interventions
DEVICErPMS device
Pelvic floor muscle contractions will be induced by the rPMS device.
PROCEDUREPelvic floor muscle training
Control group will undergo a pelvic floor muscle training
Sponsors
BTL Industries Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 70 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pelvic floor muscle strength | 13 months | Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups. |
| Evaluation of incontinence episodes using Bladder diary | 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 ICIQ-LUTSqol questionnaire | 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 quality of life improvement using the Pad Usage Questionnaire | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy comfort evaluation | 1 month | Evaluation of therapy comfort after each treatment or training session using the questionnaire. |
| Safety evaluation | 13 months | Incidence of adverse events (AE) associated with study device will be followed. |
| Subject Satisfaction evaluation | 13 months | Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment. |
Countries
United States
Outcome results
None listed