Urinary Stress Incontinence and Urgency in Women With EMSELLA

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)

Conditions
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Stress Urinary Incontinence, Urge Incontinence

Intervention / Treatment
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* Device: BTL EMSELLA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active and sham arms 2:1 run parallel. Upon completion, sham patients repeat visits with open label treatment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active EMSELLA treatment<br>6 treatments on the BTL EMSELLA using a device protocol that is active HIFEM technology | Device: BTL EMSELLA<br>* 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.<br>|
| Sham Comparator: Sham EMSELLA treatment<br>6 treatments on the BTL EMSELLA with a sham device protocol that provides some sensation without active HIFEM technology | Device: BTL EMSELLA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Serious adverse events and adverse events related to device will be collected to assess safety | 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 | At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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) | 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. | 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. | At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence, stress urgency incontinence, urge incontinence, EMSELLA