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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: rPMS device

• Registration Number: NCT03942484
• Lead Sponsor: BTL Industries Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-18
• Study Start: 2019-05-01
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Primary Completion: 2020-12-30
• Study Completion: 2021-10-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	rPMS device	Treatment with the investigational device - rPMS

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.	18 months	Incidence of adverse events (AE) associated with study device will be followed.

Trial Locations

Locations (5)

Gynecological Solutions; 🇺🇸 Hillsborough, New Jersey, United States

Julene Samuels; 🇺🇸 Louisville, Kentucky, United States

Southern Urogynecology; 🇺🇸 West Columbia, South Carolina, United States

Joseph Berenholz; 🇺🇸 Farmington Hills, Michigan, United States

Hillcroft Medical Clinic; 🇺🇸 Sugar Land, Texas, United States