rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
NCT ID: NCT03969368
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-06-01
2022-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
Treatment with the investigational device - rPMS
rPMS device
Pelvic floor muscle contractions will be induced by the rPMS device.
Control Group
Control group
Pelvic floor muscle training
Control group will undergo a pelvic floor muscle training
Interventions
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rPMS device
Pelvic floor muscle contractions will be induced by the rPMS device.
Pelvic floor muscle training
Control group will undergo a pelvic floor muscle training
Eligibility Criteria
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Inclusion Criteria
* 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 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
25 Years
70 Years
FEMALE
No
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Boston Urogyn
Wellesley, Massachusetts, United States
Center for Urogynecology and Reconstructive Surgery
Somerset, New Jersey, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, United States
The Female Pelvic Medicine Institute
Richmond, Virginia, United States
Countries
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Other Identifiers
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BTL-099-U2
Identifier Type: -
Identifier Source: org_study_id
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