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

  • STATUS
    Recruiting
  • End date
    Oct 29, 2024
  • participants needed
    110
  • sponsor
    William Beaumont Hospitals
Updated on 29 May 2022
prostatectomy
cough
sneezing
anticholinergics
incontinence
stress test
leakage of urine
adrenergic blockers

Summary

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.

Description

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.

Details
Condition Stress Urinary Incontinence
Treatment BTL Emsella, Sham BTL Emsella
Clinical Study IdentifierNCT04133675
SponsorWilliam Beaumont Hospitals
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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 has a malignant tumor, in any location in the body
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
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