Clinical trial NCT03877640: Urinary Stress Incontinence and Urgency in Women With EMSELLA
Official title: A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Urge Incontinence
Keywords: incontinence
stress urgency incontinence
urge incontinence
EMSELLA
Lead sponsor: San Diego Sexual Medicine
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 21
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active and sham arms 2:1 run parallel. Upon completion, sham patients repeat visits with open label treatment.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

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 psychologic disorder 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 the O'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 pain questions 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 pain questions 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 it before each treatment;
17. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic 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 Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 18 weeks for active arm; up to 32 weeks for sham arm
measure: QUID (Questionnaire for Urinary Incontinence Diagnosis)
timeFrame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Secondary outcomes:
measure: FSFI (Female Sexual Function Index) Orgasm Domain
timeFrame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
measure: FSFI (Female Sexual Function Index)
timeFrame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
measure: FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm)
timeFrame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
measure: ISCI (Interstitial Cystitis Symptoms Index )/ICPI (Interstitial Cystitis Problem Index)
timeFrame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
measure: Modified Oxford Scale measuring pelvic floor strength
timeFrame: At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks
Other outcomes:
measure: PGI-I (Patient global impression of improvement)
timeFrame: At 18 weeks; for sham arm additionally at 32 weeks
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
Study officials:
affiliation: Clinical Research Manager
name: Sue W Goldstein, BA
role: STUDY_DIRECTOR
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