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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Pelvic floor muscle contractions will be induced by the rPMS device.
Control group will undergo a pelvic floor muscle training
Boston Urogyn
Wellesley, Massachusetts, United States
Center for Urogynecology and Reconstructive Surgery
Somerset, New Jersey, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, United States
The Female Pelvic Medicine Institute
Richmond, Virginia, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 13 months
Evaluation of pelvic floor muscle strength
Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.
Time frame: 13 months
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.
Time frame: 13 months
Therapy comfort evaluation
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Evaluation of therapy comfort after each treatment or training session using the questionnaire.
Time frame: 1 month
Safety evaluation
Incidence of adverse events (AE) associated with study device will be followed.
Time frame: 13 months