Could a chair cure your bladder troubles?
NCT ID NCT04873037
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests whether a chair that uses electromagnetic pulses to strengthen pelvic floor muscles can help people with overactive bladder. About 166 adults who have not gotten relief from lifestyle changes or medications will sit in the chair twice a week for four weeks. Half will get the real treatment, half a sham, to see if it truly reduces urinary urgency and frequency.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BTL Emsella Chair (high-intensity focused electromagnetic device)
- What this could lead to
- If it works, this could offer a non-drug, non-surgical option to reduce urinary urgency and frequency for people with overactive bladder.
- What could go wrong
- This is an early study with no prior data on this device for overactive bladder. The sham comparison may show no real benefit, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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
-
About 166 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2021
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. Women and men ≥ 18 years of age 3. Self-reported bladder symptoms present ≥ 3 months 4. Self-reported failed conservative care of behavioral modifications and/or oral medications 5. On a stable dose of antimuscarinics/beta-3 agonists for ≥ 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for ≥ 2 weeks 6. Ambulatory and able to use a toilet independently, without difficulty 7. Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods. For Females Only: 8. 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)) Exclusion Criteria: 1. Botox® use in bladder or pelvic floor muscles in the past year 2. Subject weighs greater than 330 pounds 3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of 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 thighs, at the discretion of the investigator. 5. Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study. 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. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Skin cancers are permitted. 11. Subject has used the BTL EMSELLA device previously 12. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc. 13. Current urinary tract infection. If a subject has a confirmed symptomatic UTI at screening, per investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved 14. Current use of neuromodulation therapy, including interstim and PTNS, for bladder symptoms within 3 months of screening visit (if past sacral/pudendal implant, must be explanted) 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 * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Overactive bladder are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
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.
- Can a nerve pain drug calm the bladder?
- A gentle nerve zap may calm an overactive bladder
- Can a nerve pain drug boost bladder pain relief?
- Can a nerve pacemaker that takes breaks still tame an overactive bladder?
- Diabetes drug class may change how the bladder behaves
- Botox vs. blood plasma: which works better for a bladder that Won't quit?