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

BTL

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: rPMS device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03942484

BTL-099-S

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Treatment Group

Experimental group

Description:

Treatment with the investigational device - rPMS

Treatment:

Device: rPMS device