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NCT03942484 Clinical Trial

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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03942484
Other study ID # BTL-099-S
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date October 20, 2021

Study information
Verified date November 2021
Source BTL Industries Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date October 20, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Joseph Berenholz Farmington Hills Michigan
United States Gynecological Solutions Hillsborough New Jersey
United States Julene Samuels Louisville Kentucky
United States Hillcroft Medical Clinic Sugar Land Texas
United States Southern Urogynecology West Columbia South Carolina

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 ICIQ-UI questionnaire Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement. 18 months
Primary Evaluation of quality of life improvement using the FSFI questionnaire Evaluation of change in FSFI score. Increase of the score will be considered as an improvement. 18 months
Primary Evaluation of quality of life improvement using the PISQ-12 questionnaire Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement. 18 months
Secondary Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed. Incidence of adverse events (AE) associated with study device will be followed. 18 months
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