Comparing Emsella Chair therapy to a sham treatment for overactive bladder

A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder

This study is testing if the Emsella Chair, a new therapy that uses electromagnetic technology, can help people with overactive bladder feel better compared to a fake treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Corewell Health East (Academic / other)
• Locations: 1 site (Royal Oak, Michigan)
• Trial ID: NCT04873037 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the BTL Emsella Chair, a non-invasive neuromodulation therapy, in treating overactive bladder (OAB) symptoms compared to a sham treatment. Participants will receive two sessions per week for four weeks, focusing on improving urinary frequency and urgency. The Emsella Chair utilizes high-intensity focused electromagnetic technology to stimulate pelvic floor muscles, potentially offering a new treatment option for patients who have not responded to traditional therapies. This study is particularly relevant as there are currently no other trials using this specific approach for OAB.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 and older who have experienced bladder symptoms for at least three months and have not found relief from conservative treatments.

Not a fit: Patients who are currently undergoing other treatments for overactive bladder or those who are not able to comply with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive alternative for patients suffering from overactive bladder, improving their quality of life.

How similar studies have performed: This approach is novel and has not been tested in other studies specifically for overactive bladder treatment.

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. 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.

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: Danielle Tenney

Conditions Overactive Bladder Syndrome; Overactive Bladder; Urinary Frequency; Urinary Urgency