Actively Recruiting
A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
Led by Corewell Health East · Updated on 2025-12-11
166
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Overactive bladder (OAB) is a common condition affecting both men and women, causing symptoms like frequent urination, urgency, and urge incontinence that can lower quality of life. This clinical trial is evaluating whether the BTL Emsella Chair, a device using electromagnetic technology, is effective compared to a sham treatment for managing OAB symptoms. The study addresses the need for non-drug options due to side effects and poor adherence to medications, exploring a noninvasive therapy that stimulates pelvic floor muscles. Participants will receive either active treatment with the Emsella Chair or a sham treatment. The active treatment involves sitting on the chair twice a week for four weeks, where electromagnetic stimulation is gradually increased to the highest comfortable level to induce pelvic floor muscle contractions equivalent to thousands of Kegel exercises. The sham group will receive a similar setup but with minimal stimulation below a therapeutic threshold. Treatment sessions last about 28 minutes, aiming to rehabilitate weak pelvic floor muscles. During the study, participants will be assessed at baseline and followed through 8 to 12 weeks to measure improvements in bladder symptoms, urinary urgency, frequency, leakage, and quality of life using questionnaires and voiding diaries. Researchers will track responses using the Global Response Assessment and other validated tools to compare active versus sham effects. Safety and tolerability will also be monitored, with no new OAB treatments started during the study. The full participation lasts about 12 weeks from treatment start to final follow-up.
CONDITIONS
Brief Title
BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and provide written, dated informed consent
- Men and women aged 18 years or older
- Self-reported bladder symptoms present for 3 months or more
- Self-reported failure of conservative care like behavioral changes or oral medications
- Stable dose of antimuscarinics or beta-3 agonists for 4 weeks and willing to stay on them during the study, or discontinued these medications for at least 2 weeks
- Ambulatory and able to use a toilet independently
- Agree not to start any new overactive bladder treatments during the study and follow-up
- For women of child-bearing age, agree to use approved birth control methods
You will not qualify if you...
- Botox use in bladder or pelvic floor muscles within the past year
- Weight over 330 pounds
- Pulmonary insufficiency or symptoms like difficulty breathing, chest pain, palpitations, swelling, dizziness, or cyanosis
- Conditions causing lack of normal skin sensation in pelvis, buttocks, or thighs
- Major metal implants such as plates, screws, joint replacements, pacemakers, drug pumps, neurostimulators, electronic implants, copper IUDs, defibrillators, or pelvic metal implants
- Piercing between waist and knees not willing to be removed before each treatment
- Active urethral diverticula
- Known vesicoureteral reflux
- Healing from surgery where muscle contraction may disrupt recovery
- Current treatment for malignant tumors interfering with study participation (skin cancers allowed)
- Previous use of the BTL Emsella device
- Urinary incontinence from neurogenic causes like multiple sclerosis, Parkinson's, spinal cord injury, or diabetic neuropathy
- Current urinary tract infection
- Use of neuromodulation therapy for bladder symptoms within 3 months
- Participation in another investigational study within 30 days
- Physical conditions risking safety or interfering with results as judged by investigator
- For women: pregnant or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Over multiple sessions during the study period
Participants receive either active treatment with the BTL Emsella Chair or a sham treatment. Each treatment session involves sitting on the device for 28 minutes to stimulate pelvic floor muscles through electromagnetic technology or a sham low-level sensation.
Multiple treatment visits (in-person)
Duration - Up to 4 weeks after completing treatments
Participants are monitored for treatment effects and safety after completing all treatments, including assessments of bladder symptoms and quality of life.
1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
Research Team
D
Danielle Tenney
J
Jennifer Giordano, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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