BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCorewell Health East
About this trial
Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.
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.
Females and males, 18 to 80 years of age, inclusive, at screening
Positive Cough or Bladder Stress Test at screening
Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
Disqualifiers
Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
Subject is morbidly obese (defined as body mass index 40 or greater)
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure or 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 lower extremities
Trial design
Design model
Parallel
Treatments tested in this trial
BTL Emsella
DeviceThe 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. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimlulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
Sham BTL Emsella
DeviceSham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (\<10% power).
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Emsella Chair Active TreatmentActive comparator 1 intervention
Group B: Emsella Sham TreatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence.
The primary objective of this study is to compare the efficacy of Emsella Chair to sham by evaluating the the responder rate, where a patient is called a responder if there is ≥ 50% reduction from baseline in the number stress incontinence events.
Time frame
4 weeks after completing all treatmentsSecondary outcomes
1
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in total number of subject-reported stress urinary incontinence (SUI) episodes.
Change in the total number of subject-reported stress incontinence (SUI) episodes over 3 days based on voiding diaries. Patients will be giving a 3-day void diary to complete.
Time frame
8 weeks after completing all treatments2
The efficacy of the Emsella chair versus sham to treat SUI in relation to the change in subject-reported impression of SUI severity.
Change in subject-reported impression of SUI severity as measured by the Patient Global Impression of Severity scale (PGI-S). The subject will check the box that describes how their condition is now. The available options are normal, mild, moderate, or severe.
Time frame
8 weeks after completing all treatments3
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in subject-reported impression of SUI improvement as measured by the Patient Global Impression of Improvement scale (PGI-I).
Change in subject-reported impression of SUI improvement as measured by the Patient Global Impression of Improvement scale (PGI-I). The subject will select one of the following options, (very much better, much better, a little better, no change, a little worse, much worse, very much worse) to describe their urinary tract symptoms now versus prior to study treatment.
Time frame
8 weeks after completing all treatments4
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence related to the change in subject-reported urogenital distress.
Change in subject-reported urogenital distress as measured by the Urinary Distress Inventory questionnaire (UDI-6). The UDI-6 is a six point questionnaire, each question answered is scored as follows; 0 = no, 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit. Add all scores and divide by 6, then multiply by 25 to calculate the raw score. Higher scores = higher disability.
Time frame
8 weeks after completing all treatmentsSponsors and contacts
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Source ClinicalTrials.gov