rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969368
• Other study ID #: BTL-099-U2
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 23, 2022

Study information

• Verified date: August 2022
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 23, 2022
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• rPMS device
Pelvic floor muscle contractions will be induced by the rPMS device.

Procedure:
• Pelvic floor muscle training
Control group will undergo a pelvic floor muscle training

Locations

Country	Name	City	State
United States	The Female Pelvic Health Center	Newtown	Pennsylvania
United States	The Female Pelvic Medicine Institute	Richmond	Virginia
United States	Center for Urogynecology and Reconstructive Surgery	Somerset	New Jersey
United States	Boston Urogyn	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Evaluation of pelvic floor muscle strength	Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.	13 months
Secondary	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
Secondary	Therapy comfort evaluation	Evaluation of therapy comfort after each treatment or training session using the questionnaire.	1 month
Secondary	Safety evaluation	Incidence of adverse events (AE) associated with study device will be followed.	13 months