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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.
San Diego Sexual Medicine
San Diego, California, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Serious adverse events and adverse events related to device will be collected to assess safety
Time frame: Up to 18 weeks for active arm; up to 32 weeks for sham arm
QUID (Questionnaire for Urinary Incontinence Diagnosis)
Change in Questionnaire for Urinary Incontinence Diagnosis (QUID) from pre-treatment to each follow up visit
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSFI (Female Sexual Function Index) Orgasm Domain
Change in Orgasm Domain of the Female Sexual Function Index from pre-treatment to follow up visits. Range is 0-6 with higher the results representing better outcome
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSFI (Female Sexual Function Index)
Change in total score of the Female Sexual Function Index from pre-treatment to follow up visits. Range is 2-36, with higher results representing better the outcome, and 26.55 and above signifying no sexual dysfunction
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm)
Change in total score of the Female Sexual Distress Score-Desire, Arousal, Orgasm from pre-treatment to follow up visits. Range is from 0-60 with lower results representing the better outcome.
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
ISCI (Interstitial Cystitis Symptoms Index )/ICPI (Interstitial Cystitis Problem Index)
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Change in total score of the ICSI/ICPI Questionnaire from pre-treatment to follow up visits. Range is 0-35, with lower results representing the better the outcome.
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Modified Oxford Scale measuring pelvic floor strength
Change in degree of force based on the modified Oxford scale measuring pelvic floor muscle strength from pre-treatment to follow up visits. Scale is a single recording from 0 (lack of muscle response) to 5 (strong contraction, firm compression) with higher results representing the better the outcome.
Time frame: At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks