Last updated: October 8, 2023
Sponsor: San Diego Sexual Medicine
Overall Status: Active - Recruiting
Phase
N/A
Condition
Urinary Incontinence
Enuresis
Overactive Bladder
Treatment
BTL EMSELLA
Clinical Study ID
NCT03877640
SDSM-2018-02
Ages 21-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject provides written informed consent and HIPAA authorization before any studyprocedures are conducted;
- Subject is female;
- Subject is aged 21-80 years;
- Subject has a body mass index (BMI) < 37 kg/m2;
- Subject has stress urinary incontinence, urge incontinence, or mixed urinaryincontinence as determined by the QUID;
- Subject is currently sexually active and willing to continue sexual activitythroughout the study;
- Subject is willing to continue level of core exercise currently being performed or notperformed during the study (e.g. gym, Pilates, yoga);
- Subject is willing to maintain her current prescription and over the countermedications throughout the study without changing them;
- Subject agrees to comply with the study procedures and visits.
Exclusion
Exclusion Criteria:
- Subject has used the BTL EMSELLA device previously;
- Subject has any significant pelvic organ prolapse;
- Subject has clinically significant findings on physical examination;
- Subject has any chronic medical condition (e.g. neurologic disorder) or psychologicdisorder that the Principal Investigator feels makes her ineligible for the study;
- Subject is unwilling to maintain current level of exercise throughout the study;
- Subject has been diagnosed with overactive bladder or interstitial cystitis;
- Subject experiences bladder pain or scores above 0 on the pain questions on theO'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
- Subject experiences pain with sexual activity
- Subject answers anything other than "almost never or never" or "a few times" on painquestions 17 or 18 of the Female Sexual Function Index (FSFI)
- Subject answers anything other than "very low or none at all" or "low" on painquestions 19 of the (FSFI)
- Subject planning to have surgery during the study;
- Subject has untreated malignancy;
- Subject is pregnant, planning to get pregnant or within 3 months postpartum;
- Subject has a pacemaker;
- Subject has and implant or IUD containing metal (e.g. copper 7);
- Subject has piercing between the waist and knees and is not willing to remove itbefore each treatment;
- Subject has a history of substance abuse within 12 months prior, or consuming > 14alcoholic drinks per week;
- Subject has received an investigational drug within 30 days prior to signing consent;
- Subject has any condition or exhibits behavior that indicates to the PrincipalInvestigator that the Subject is unlikely to be compliant with study procedures andvisits.
Study Design
Total Participants: 21
Treatment Group(s): 1
Primary Treatment: BTL EMSELLA
Phase:
Study Start date:
January 11, 2019
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
San Diego Sexual Medicine
San Diego, California 92120
United StatesActive - Recruiting
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