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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID: NCT04133675
Run by: Corewell Health East
People needed: 110
Starts: 2019-12-18
Expected to finish: 2028-12-01
Last updated by the study team: 2026-07-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
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.

Where it is running

Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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