Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Using the Emsella Chair to treat stress urinary incontinence

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

Run by Corewell Health East · NCT04133675 · Data updated 2026-11-12

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.

More Stress Urinary Incontinence trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment110 (estimated)
SponsorCorewell Health East
Academic / other
Locations1 site (Royal Oak, Michigan)
StatusRecruiting
StartedDecember 18, 2019
Main results expectedOctober 2028
Study endsDecember 2028
Registry record updatedJuly 9, 2026
Trial IDNCT04133675 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Corewell Health William Beaumont University Hospital
    Royal Oak, Michigan, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.