Can a special chair stop leaks when you laugh or sneeze?
NCT ID NCT04133675
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests a chair called Emsella that uses electromagnetic energy to treat stress urinary incontinence—leaking urine when coughing, sneezing, or exercising. About 110 adults aged 18 to 80 will sit in either the real chair or a fake (sham) chair to see if it reduces leaks by at least half. The goal is to find a non-invasive way to improve quality of life without surgery or medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Corewell Health William Beaumont University Hospital
RECRUITINGRoyal Oak, Michigan, 48073, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Shoes that train your pelvic floor without you knowing
- Can your own blood help stop leakage? a new trial investigates
- Could a blood flow drug strengthen pelvic muscles to curb incontinence?
- Can ancient qigong movements fortify pelvic health after childbirth?
- Can a single dose of muscle cells hold up for years against stubborn incontinence?