rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: rPMS device; Procedure: Pelvic floor muscle training

• Registration Number: NCT03969368
• Lead Sponsor: BTL Industries Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Study Start: 2019-06-01
• Primary Completion: 2021-07-23
• Study Completion: 2022-06-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	rPMS device	Treatment with the investigational device - rPMS
Control Group	Pelvic floor muscle training	Control group

Primary Outcome Measures

Name	Time	Method
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 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.
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 pelvic floor muscle strength	13 months	Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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