BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health East
About this trial
The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.
Women and men ≥ 18 years of age
Self-reported bladder symptoms present ≥ 3 months
Self-reported failed conservative care of behavioral modifications and/or oral medications
Disqualifiers
Botox® use in bladder or pelvic floor muscles in the past year
Subject weighs greater than 330 pounds
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
BTL Emsella Chair
DeviceThe Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
Sham BTL Emsella Chair
DeviceThe sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (less than 10%) power.
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Emsella Chair Active TreatmentActive comparator 1 intervention
Group B: Emsella Chair Sham TreatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compare the efficacy of Emsella Chair versus Sham by evaluating the proportion of subjects reporting "moderately improved" or "markedly improved" responses on the Global Response Assessment (GRA) for overall bladder symptoms.
The GRA evaluates the patients' perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved).
Time frame
4 weeks after completing all treatments; week 8 of the studySecondary outcomes
1
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported urinary urgency, frequency, and leakage episodes as reported in a 3-day voiding diary.
Subjects will record all urinary voids, specifying each episode of urination, urinary leakage, including type, urinary urgency before voiding. In each 3-day voiding diary, subjects are to record voiding data for 3 consecutive days on a paper diary. To be considered valid, each 3-day voiding diary must be recorded within 7 days on either side of a planned visit, based on the date of randomization.
Time frame
4 weeks after completing all treatments; week 8 of the study2
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported overactive bladder symptoms as measured by the Overactive Bladder Questionnaire-Short form (OAB-q).
The OAB-q short form is a disease-specific questionnaire that assesses symptom bother and health related quality of life (HRQL) in people with OAB. The OAB-q short form consists of a 6-item symptom bother scale and a 13- item HRQL scale. A higher score indicates a greater severity of symptom bother.
Time frame
4 weeks after completing all treatments; week 8 of the study3
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life questionnaire (I-QOL).
The I-QOL is a self-reported quality of life measure specific to urinary problems that can be used to assess the impact of urinary problems and their treatment. The I-QOL is a 22 item measure that is divided into three domains: 1) 8-item domain assessing the physical impact of urinary incontinence. 2) 9-item domain assessing psychological impact 3) 5-item domain assessing social impact. Scores are calculated for each domain, and a total summary score can be calculated from all 22 items. A higher scores indicates a greater severity of symptoms on quality of life.
Time frame
4 weeks after completing all treatments; week 8 of the study4
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported OAB symptoms (urinary incontinence, urinary urgency, urinary frequency) since start of the study as measured by Global Response Assessment (GRA)
The GRA evaluates the patients' perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved). Three separate GRA's will be administered 1. Urinary incontinence 2. Urinary frequency 3. Urinary urgency
Time frame
4 weeks after completing all treatments; week 8 of the studySponsors and contacts
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Source ClinicalTrials.gov