BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, sham-controlled, observational study of subjects undergoing electromagnetic perineal stimulation for the treatment of SUI. Eligible subjects will be randomized to receive active treatment or sham in a 1:1 ratio. Eight treatments (2 treatments each week) for 4 weeks will be completed with the Emsella chair to the pelvic floor muscles. Electromagnetic stimulation of the pelvic floor is a FDA approved therapy whereby a coil generates pulsed electromagnetic fields that penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation of weak pelvic 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.This technology is typically not covered by insurance, is minimally invasive, and safe, but has limited data available. Currently, there is no data available from sham controlled studies evaluating efficacy of this technology. The purpose of this study is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of SUI.

Official Title
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A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: BTL Emsella
* Device: Sham BTL Emsella


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 6. Subject agrees to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonist, or α-adrenergic blockers, throughout the treatment and follow-up periods. For Females Only: Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods. If of child-bearing age and female, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginal contraceptive ring, IUD, implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s)) For Males Only: - Subject must be ≥ 4 months post radical prostatectomy Exclusion Criteria: 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 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 lower extremities Implanted cardiac pacemaker or metal in the body, including, but not limited to drug pumps, neurostimulators, electronic implants, copper intrauterine devices (IUDs), and/or defibrillators Subject has a piercing between the waist and knees and is not willing to remove it before each treatment Active urethral diverticula Known vesicoureteral reflux Currently healing from surgical procedures where muscle contraction may disrupt the healing process Treatment with urethral bulking agents within the 6 months prior to the Screening Visit Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Subject has used the BTL EMSELLA device previously Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc. Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation For Females Only: Pregnant, or planning to become pregnant, at screening or anytime throughout the study period History of surgery with insertion of vaginal mesh for SUI Vaginal prolapse beyond the introitus Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit Note for the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Subjects will be randomized 1:1 to receive active Emsella chair treatments or sham treatments. Study will be performed in a single-blind manner.(Participant and biostatistician)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Emsella Chair Active Treatment<br>Active treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. The Emsella chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%. | Device: BTL Emsella<br>* 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. 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.<br>|
| Sham Comparator: Emsella Sham Treatment<br>Sham 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). | Device: Sham BTL Emsella<br>* Sham 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks after completing all treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks after completing all treatments | 
| 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. | 8 weeks after completing all treatments | 
| 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. | 8 weeks after completing all treatments | 
| 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. | 8 weeks after completing all treatments | 
| The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in subject-reported impact of SUI on daily life. | Change in subject-reported impact of SUI on daily life as measured by the Incontinence Impact Questionnaire (IIQ-7) Short Form. The IIQ-7, assesses how their problem effects activities, relationships, and feelings. It is a 7 point questionnaire. Each answer is scored on the following scale 0 = not at all, 1 = slightly, 2 = moderately, 3 = greatly. The higher the score the more effected they are by their condition. | 8 weeks after completing all treatments | 
| The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in subject-reported impact of urinary incontinence on daily life measured by the Incontinence Quality of Life questionnaire (I-QOL). | 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 quality of life measure specific to persons with urinary incontinence. The survey consists of 22 incontinent-specific quality of life items all having the following five-point ordinal response; 1 = extremely, 2 = quite a bit, 3 = moderately, 4 = a little, 5 = not at all. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life). | 8 weeks after completing all treatments | 
| The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and the change in fecal incontinence as measured by the Cleveland clinic incontinence score (Wexner). | Change in subject-reported fecal incontinence as measured by the Cleveland clinic incontinence score (Wexner). The type of incontinence of stool (solid, liquid, gas, wears pad, lifestyle altered) are reported by the subject. Each question is measured as 0 = never, 1 = rarely, 2 = sometimes, 4 = usually, 5 = always. The higher the score the more severe the condition. | 8 weeks after completing all treatments | 
| The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and the change in subject-reported sexual function as measured by Female Sexual Function Index questionnaire for female subjects. | The change in subject-reported sexual function as measured by the Female Sexual Function Index questionnaire (FSFI) for female subjects. The FSFI is a 19 question survey. A lower the score is equivalent a higher degree of sexual function. Scores range from 0 to 95. | 8 weeks after completing all treatments | 
| The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and the change in subject-reported sexual function as measured by the Brief Sexual Function Inventory questionnaire (BSFI) for male subjects. | Change in subject-reported sexual function as measured by the Brief Sexual Function Inventory questionnaire (BSFI) for male subjects. The BSFI is a validated questionnaire for male sexual function. Scores range from 0 to 44. A lower score indicates a higher degree of dysfunction. | 8 weeks after completing all treatments | 
| The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and change in reported pain and discomfort. | Change in subject-reported pain and discomfort as measured by the Visual Analog Scale (VAS). The VAS is a validated questionnaire that assesses pain on a scale from 0 = no pain to 10 = Worst possible pain. | 8 weeks after completing all treatments | 
| Durability to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group | The secondary object for durability for this study are to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group | 8 weeks after primary efficacy endpoint | 
| Safety objective to determine the safety and tolerability of Emsella Chair compared to sham | Safety and tolerability of the Emsella chair compared to Sham will be assessed in relation the incidence of adverse events. | 4 weeks after primary efficacy endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, urine leakage