Urinary Stress Incontinence and Urgency in Women With EMSELLA

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence, Urge Incontinence

In brief

The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment of women with stress urinary incontinence (SUI), urge incontinence (UI) and mixed stress urinary and urge incontinence (MUI), looking at any potential sexual health benefits that may be concomitantly achieved from this treatment.

Key facts

Study ID: NCT03877640
Run by: San Diego Sexual Medicine
People needed: 21
Starts: 2019-01-11
Expected to finish: 2024-06-01
Last updated by the study team: 2023-10-10

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Subject provides written informed consent and HIPAA authorization before any study procedures 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 urinary incontinence as determined by the QUID;
Subject is currently sexually active and willing to continue sexual activity throughout the study;
Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
Subject agrees to comply with the study procedures and visits.

You may not qualify if…

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 psychologic disorder 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 the O'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 pain questions 17 or 18 of the Female Sexual Function Index (FSFI)
Subject answers anything other than "very low or none at all" or "low" on pain questions 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 it before each treatment;
Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic 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 Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

Where it is running

San Diego Sexual Medicine — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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