rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

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

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 Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: rPMS device; Procedure: Pelvic floor muscle training

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
      • Boston Urogyn
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Center for Urogynecology and Reconstructive Surgery
  • Pennsylvania
    • Newtown, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
  • Virginia
    • Richmond, Virginia, United States, 23225
      • The Female Pelvic Medicine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group; Treatment with the investigational device - rPMS	Device: rPMS device; Pelvic floor muscle contractions will be induced by the rPMS device.
ACTIVE_COMPARATOR: Control Group; Control group	Procedure: Pelvic floor muscle training; Control group will undergo a pelvic floor muscle training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): July 23, 2021
• Study Completion (ACTUAL): June 23, 2022

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: BTL-099-U2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No