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Compares treatment options for Overactive Bladder Syndrome
Official title BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
ClinicalTrials.gov ID: NCT04873037
What this study is testing
- What it's testing
- The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including...
- Women and men ≥ 18 years of age
- Self-reported bladder symptoms present ≥ 3 months
- Self-reported failed conservative care of behavioral modifications and/or oral medications
- 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...
You likely can't join if
- Botox® use in bladder or pelvic floor muscles in the past year
- Subject weighs greater than 330 pounds
- Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of...
- Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
- Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic...
- Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
See the full eligibility criteria
Who can join
- 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...
- Women and men ≥ 18 years of age
- Self-reported bladder symptoms present ≥ 3 months
- Self-reported failed conservative care of behavioral modifications and/or oral medications
- 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
- Ambulatory and able to use a toilet independently, without difficulty
- Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods. For Females Only:
- 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...
What rules you out
- Botox® use in bladder or pelvic floor muscles in the past year
- Subject weighs greater than 330 pounds
- 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)...
- Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
- 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...
- Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
- Active urethral diverticula
- Known vesicoureteral reflux
- Currently healing from surgical procedures where muscle contraction may disrupt the healing process
- Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Skin cancers are permitted.
- Subject has used the BTL EMSELLA device previously
- Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc.
- 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...
- 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)
- 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
- 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:
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Royal Oak, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Royal Oak, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.