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

Corewell Health East110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Stress Urinary Incontinence

Interventions

BTL EmsellaDEVICE

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.

Sham BTL EmsellaDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Females and males, 18 to 80 years of age, inclusive, at screening 3. Positive Cough or Bladder Stress Test at screening 4. 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: 1. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening 2. Subject is morbidly obese (defined as body mass index 40 or greater) 3. 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) 4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities 5. 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 6. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment 7. Active urethral diverticula 8. Known vesicoureteral reflux 9. Currently healing from surgical procedures where muscle contraction may disrupt the healing process 10. Treatment with urethral bulking agents within the 6 months prior to the Screening Visit 11. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. 12. Subject has used the BTL EMSELLA device previously 13. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc. 14. Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit 15. 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 16. 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: 17. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period 18. History of surgery with insertion of vaginal mesh for SUI 19. Vaginal prolapse beyond the introitus 20. 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.

Locations (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

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 treatments

Secondary Outcomes

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 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.

Time frame: 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.

Time frame: 8 weeks after completing all treatments

Central Contacts

Julie Swanson, RN

CONTACT

248-551-3551 Julie.Swanson2@corewellhealth.org

Jennifer Giordano, RN

CONTACT

248-551-3517 Jennifer.Giordano@corewellhealth.org

Data from ClinicalTrials.gov

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