rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

BTL

Status: Completed

Conditions: Urinary Incontinence

Treatments: Procedure: Pelvic floor muscle training; Device: rPMS device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03969368

BTL-099-U2

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Treatment with the investigational device - rPMS

Treatment:

Device: rPMS device

Control Group

Active Comparator group

Description:

Control group

Treatment:

Procedure: Pelvic floor muscle training