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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Corewell Health East Academic / other |
| Locations | 1 site (Royal Oak, Michigan) |
| Status | Recruiting |
| Started | December 18, 2019 |
| Main results expected | October 2028 |
| Study ends | December 2028 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT04133675 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
- Principal investigator: Kenneth Peters, MD — Corewell Health William Beaumont University Hospital
- Study coordinator: Katherine Kim, RN
- Email: Katherine.Kim@corewellhealth.org
- Phone: 248-551-0642
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
See if increasing running cadence helps stress urinary incontinence in parous runners
This study tests whether increasing running cadence by about 10% for eight weeks can reduce stress urinary incontinence symptoms in parous women who run regularly and own a Garmin watch.
-
Prophylactic antibiotics to reduce post-procedure UTIs after urethral bulking
We’re testing whether giving a preventive antibiotic at the time of urethral bulking can lower the chance of a urinary tract infection after the procedure for women with stress or mixed urinary incontinence.
-
Evaluating the impact of different mesh widths in surgery for urinary incontinence
This study is testing whether using a wider surgical mesh during surgery for urinary incontinence in women can lead to better results and fewer problems.
-
Evaluating postoperative activity restrictions after midurethral sling placement
This study is testing whether patients who have had a midurethral sling procedure for stress urinary incontinence do better with strict activity limits or no limits after surgery.
-
Comparing two procedures for treating stress urinary incontinence during vaginal prolapse repair
This study is testing whether a new type of surgery or an injection is better for helping women with stress urinary incontinence during vaginal prolapse repair.
-
Effectiveness and safety of shorter tapes for urinary incontinence
This study looks at whether shorter surgical tapes for treating urinary incontinence in women can improve their quality of life and have fewer complications compared to longer tapes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.