Urinary Stress Incontinence and Urgency in Women With EMSELLA

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject provides written informed consent and HIPAA authorization before any studyprocedures are conducted;
  2. Subject is female;
  3. Subject is aged 21-80 years;
  4. Subject has a body mass index (BMI) < 37 kg/m2;
  5. Subject has stress urinary incontinence, urge incontinence, or mixed urinaryincontinence as determined by the QUID;
  6. Subject is currently sexually active and willing to continue sexual activitythroughout the study;
  7. Subject is willing to continue level of core exercise currently being performed or notperformed during the study (e.g. gym, Pilates, yoga);
  8. Subject is willing to maintain her current prescription and over the countermedications throughout the study without changing them;
  9. Subject agrees to comply with the study procedures and visits.

Exclusion

Exclusion Criteria:

  1. Subject has used the BTL EMSELLA device previously;
  2. Subject has any significant pelvic organ prolapse;
  3. Subject has clinically significant findings on physical examination;
  4. Subject has any chronic medical condition (e.g. neurologic disorder) or psychologicdisorder that the Principal Investigator feels makes her ineligible for the study;
  5. Subject is unwilling to maintain current level of exercise throughout the study;
  6. Subject has been diagnosed with overactive bladder or interstitial cystitis;
  7. Subject experiences bladder pain or scores above 0 on the pain questions on theO'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
  8. Subject experiences pain with sexual activity
  9. 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)
  10. Subject answers anything other than "very low or none at all" or "low" on painquestions 19 of the (FSFI)
  11. Subject planning to have surgery during the study;
  12. Subject has untreated malignancy;
  13. Subject is pregnant, planning to get pregnant or within 3 months postpartum;
  14. Subject has a pacemaker;
  15. Subject has and implant or IUD containing metal (e.g. copper 7);
  16. Subject has piercing between the waist and knees and is not willing to remove itbefore each treatment;
  17. Subject has a history of substance abuse within 12 months prior, or consuming > 14alcoholic drinks per week;
  18. Subject has received an investigational drug within 30 days prior to signing consent;
  19. 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

This is a blinded study to be conducted at San Diego Sexual Medicine in San Diego, CA. Participants meeting inclusion and exclusion criteria will receive one treatment cycle of active treatment or sham. The device will be equipped with 3 protocols in addition to the standard protocol, two of which are identical to the standard protocol (for active treatment) and one of which does not deliver HIFEM (for sham treatment). The active treatment arm consists of 6 treatments, 2 per week, with at least one day in between. Follow-up visits will occur at 4 weeks and 12 weeks after the last treatment. Unblinding will take place at the 12 week follow up visit, and subjects assigned to the sham arm will be crossed over to active treatment, beginning their first treatment on that day, completing 6 treatments and 2 follow up visits. Once unblinded the subject will be treated with the standard protocol of the device.

After the informed consent is signed, and inclusion and exclusion criteria completed, participants will complete validated questionnaires and undergo a baseline physical therapy assessment of pelvic floor muscle strength.

Connect with a study center

  • San Diego Sexual Medicine

    San Diego, California 92120
    United States

    Active - Recruiting

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