Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
NCT ID: NCT03942484
Last Updated: 2021-11-10
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
45 participants
INTERVENTIONAL
2019-05-01
2021-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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 device.
Interventions
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rPMS device
Pelvic floor muscle contractions will be induced by the device.
Eligibility Criteria
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Inclusion Criteria
* Voluntarily signed informed consent form
* Suffers from UI
* Sexually active
* FSFI Questionnaire score ≤ 26.55 points
Exclusion Criteria
* 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
21 Years
65 Years
FEMALE
No
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Julene Samuels
Louisville, Kentucky, United States
Joseph Berenholz
Farmington Hills, Michigan, United States
Gynecological Solutions
Hillsborough, New Jersey, United States
Southern Urogynecology
West Columbia, South Carolina, United States
Hillcroft Medical Clinic
Sugar Land, Texas, United States
Countries
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Other Identifiers
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BTL-099-S
Identifier Type: -
Identifier Source: org_study_id