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.
Overactive bladder (OAB) is a common and often debilitating condition in both men and women. OAB symptoms including urinary frequency, urgency, and/or urge incontinence (UI), have been found to negatively impact quality of life. Due to side effects and the lack of patient compliance to pharmacologic treatments for OAB, non-pharmacologic treatments are in high demand for this condition. Neuromodulation therapies have become increasingly popular for the treatment of overactive bladder in men and women. These neuromodulation therapies work in treating OAB by stimulating the pudendal nerve. The BTL EmsellaTM (Emsella Chair) is a conservative neuromodulation therapy that may have a role for patients who are not surgical candidates or who desire a noninvasive treatment option. The ideal treatment for OAB is still lacking. Many patients are interested in pursuing conservative treatment options. The Emsella chair may have a role for patient who do not desire surgery found with SNM or desire a noninvasive treatment option. The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The 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.
The 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.
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
RECRUITINGCompare 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 study
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 study
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 study
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.
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Enrollment
166
Time frame: 4 weeks after completing all treatments; week 8 of the study
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 study
Compare the efficacy of Emsella chair versus Sham by the change in subject-reported fecal incontinence as measured by the Wexner Cleveland Clinic Incontinence Score (Wexner Scale).
The Wexner Scale is a self-administered questionnaire to assess the frequency and severity of fecal incontinence. The score takes into account the type and frequency of incontinence and the extent to which it alters the patient's life. The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates a greater severity of fecal incontinence.
Time frame: 4 weeks after completing all treatments; week 8 of the study
The secondary durability objective for this study is to determine whether subjects in the Emsella Chair active treatment group continue to have a higher responder rate, as measured by the GRA for overall bladder health, compared to the Sham group.
The GRA evaluates the patients' perception of improvement in overall bladder symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved).
Time frame: Treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study
The secondary safety objective of this study is to determine the safety and tolerability of Emsella Chair active treatment group compared to Sham.
Safety and tolerability of the Emsella chair compared to sham will be assessed in relation to the incidence of adverse events reported.
Time frame: 4 weeks after the primary endpoint visit; week 12