Using the Emsella Chair to treat stress urinary incontinence

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

This study is testing if the Emsella chair, which uses electromagnetic technology, can help people with stress urinary incontinence by strengthening their pelvic floor muscles.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Corewell Health East (other)
• Locations: 1 site (Royal Oak, Michigan)
• Trial ID: NCT04133675 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Emsella chair, which uses electromagnetic technology, in treating stress urinary incontinence (SUI). Participants will be randomly assigned to receive either active treatment with the Emsella chair or a sham treatment in a 1:1 ratio. The treatment consists of eight sessions over four weeks, focusing on stimulating the pelvic floor muscles to improve their strength and function. The study aims to provide data on the efficacy of this novel approach compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 80 who experience stress urinary incontinence and can comply with the study protocol.

Not a fit: Patients who are currently using bladder support devices or have recently started new treatments affecting urinary function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from stress urinary incontinence.

How similar studies have performed: While there is limited data from sham-controlled studies on this specific technology, similar approaches using electromagnetic stimulation have shown promise in other contexts.

Eligibility criteria

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.

Where this trial is running

Royal Oak, Michigan

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

Study contacts

• Principal investigator: Kenneth Peters, MD — Corewell Health William Beaumont University Hospital
• Study coordinator: Julie Swanson, RN

Conditions: Stress Urinary Incontinence, urinary incontinence, urine leakage