Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function

November 9, 2021 updated by: BTL Industries Ltd.

Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function

Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Julene Samuels
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Joseph Berenholz
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Gynecological Solutions
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Southern Urogynecology
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Hillcroft Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 21 and 65 years
  • Voluntarily signed informed consent form
  • Suffers from UI
  • Sexually active
  • FSFI Questionnaire score ≤ 26.55 points

Exclusion Criteria:

  • Suffers from other types of urinary incontinence other than SUI, UUI, MUI
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life improvement using the ICIQ-UI questionnaire
Time Frame: 18 months
Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.
18 months
Evaluation of quality of life improvement using the FSFI questionnaire
Time Frame: 18 months
Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.
18 months
Evaluation of quality of life improvement using the PISQ-12 questionnaire
Time Frame: 18 months
Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
Time Frame: 18 months
Incidence of adverse events (AE) associated with study device will be followed.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BTL Industries Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTL-099-S

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Clinical Trials on rPMS device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe