Emsella Chair Therapy for Overactive Bladder

(EmsellaOAB Trial)

Recruiting at 1 trial location

Overseen By Danielle Tenney

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Must be taking: Antimuscarinics, Beta-3 agonists

Must not be taking: Neuromodulation therapy

Disqualifiers: Pulmonary insufficiency, Major metal implants, Neurogenic incontinence, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating overactive bladder (OAB) using the Emsella Chair, which employs electromagnetic technology. Participants will receive either active treatment from the chair or a sham treatment that feels similar but lacks activity. The trial aims to determine if the Emsella Chair can effectively reduce OAB symptoms, such as frequent urination or urgent needs to go. It suits individuals who have experienced bladder problems for at least three months without relief from other treatments. As an unphased trial, it provides an opportunity to explore innovative treatment options for those seeking new solutions.

Will I have to stop taking my current medications?

If you are on a stable dose of antimuscarinics or beta-3 agonists, you can continue taking them during the study. If you have stopped these medications, you must have done so at least 2 weeks before joining the trial. You should not start any new treatments for overactive bladder during the study.

What prior data suggests that the Emsella Chair therapy is safe for treating overactive bladder?

Research has shown that the BTL Emsella Chair is generally safe for most people. It uses electromagnetic waves to strengthen pelvic muscles, which can help with urinary issues like stress incontinence. This treatment has received approval for stress urinary incontinence, indicating its safety.

However, some side effects have been reported, including pelvic pain, changes in bowel habits such as constipation or diarrhea, and occasionally late periods. Some individuals also experienced a yellow vaginal discharge and discomfort during urination.

Overall, despite some side effects, studies consider the Emsella Chair safe. It is important to consult a healthcare provider about any concerns before starting a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emsella Chair therapy for overactive bladder because it introduces a non-invasive approach using high-intensity focused electromagnetic (HIFEM) technology. Unlike traditional treatments like medications or surgical options, the Emsella Chair allows patients to remain fully clothed while experiencing targeted pelvic floor muscle stimulation. This method is not only convenient but also aims to improve muscle control and bladder function without the side effects associated with drugs. Additionally, the ease of use and quick sessions make it a promising alternative for those seeking relief with minimal disruption to their daily routine.

What evidence suggests that the Emsella Chair is effective for treating overactive bladder?

Research shows that the BTL Emsella Chair has received approval for treating stress urinary incontinence (SUI). In this trial, participants will receive either the Emsella Chair Active Treatment, which uses High-Intensity Focused Electromagnetic (HIFEM) technology to strengthen pelvic muscles, or the Emsella Chair Sham Treatment, which provides some sensation without active HIFEM technology. Although specific studies for overactive bladder (OAB) are not yet available, this technology might also improve bladder control for OAB. Early data indicates positive results for similar bladder issues, suggesting potential benefits for OAB patients. ^{2 3 4 6 7}

Who Is on the Research Team?

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with overactive bladder symptoms lasting at least 3 months, who've tried and failed conservative treatments. They must be on stable medication or have stopped such medications for two weeks, able to use the toilet without help, not start new OAB treatments during the study, and if female of child-bearing age, agree to use birth control.

Inclusion Criteria

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

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))

I have tried and not improved with standard treatments like behavior changes or pills.

Exclusion Criteria

You have used the BTL EMSELLA device before.

You weigh more than 330 pounds.

Pregnant, or planning to become pregnant, at screening or anytime throughout the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Emsella Chair or Sham treatment twice a week for 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Durability Assessment

Assessment of treatment durability and safety 4 weeks after primary endpoint

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL Emsella Chair
• Sham BTL Emsella Chair

Trial Overview The trial tests the Emsella Chair's electromagnetic technology against a sham (fake treatment) to see if it helps treat overactive bladder. Participants will receive either real or sham therapy twice weekly for four weeks.

How Is the Trial Designed?

Group I: Emsella Chair Active Treatment Active Control 1 Intervention

Active subjects will be asked to sit on the center of the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the reminder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Group II: Emsella Chair Sham Treatment Placebo Group 1 Intervention

Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (less than 10% power).

BTL Emsella Chair is already approved in United States for the following indications:

Approved in United States as BTL Emsella Chair for:

• Urinary incontinence in women and men
• Sexual dysfunction including erectile dysfunction

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Published Research Related to This Trial

Patient-reported outcomes are increasingly important in clinical trials for assessing treatment efficacy in overactive bladder syndrome (OAB), highlighting the need for reliable measurement tools.

The article reviews various health-related quality-of-life questionnaires specific to OAB, emphasizing the importance of selecting validated instruments for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective measures of efficacy and quality of life in overactive bladder syndrome. Nguyen, A., Sand, PK.[2021]

For patients with overactive bladder (OAB) who do not respond to conventional treatments, alternative therapies like electromotive drug administration (EMDA), botulinum toxin injections, and sacral neuromodulation have shown significant improvements in bladder function and quality of life.

These alternative treatments are considered effective and safe, while more invasive options like augmentation cystoplasty or cystectomy are reserved for the most severe cases, highlighting a stepwise approach to managing refractory OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy-refractory overactive bladder: alternative treatment approaches]. Knüpfer, S., Hamann, M., Naumann, CM., et al.[2021]

In a study of 65 patients undergoing thoracolumbar spine reconstruction after tumor removal, PMMA cement spacers were found to provide equivalent stability and longevity compared to expandable metallic cages (EC) without significant differences in complications or reoperations.

Using PMMA spacers resulted in substantial cost savings of $6,356 per case, making it a more economical option for spine reconstruction in metastatic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and cost-minimization analysis of cement spacers versus expandable cages for posterior-only reconstruction of metastatic spine corpectomies. Jordan, Y., Buchowski, JM., Mokkarala, M., et al.[2022]

In a study using 20 human cervical spine specimens, the new porous TiO2/glass composite interbody fusion cage (Ecopore) demonstrated significantly less increase in range of motion (ROM) compared to PMMA, indicating better stability after fusion.

The research confirmed the feasibility of using biomechanical cadaveric examinations for evaluating new materials, providing foundational data for future in vivo testing of the Ecopore cage in cervical sheep spines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biomechanicsl evaluation of a stand-alone interbody fusion cage based on porous TiO2/glass-ceramic on the human cervical spine]. Korinth, MC., Moersch, S., Ragoss, C., et al.[2019]

In a study of 153 women with overactive bladder (OAB), 65% expected to completely stop leaking after treatment, indicating a strong desire for a 'cure' and a correlation between expectations and quality of life (QoL) improvements.

While conservative measures and lifestyle changes were generally accepted, many women were less willing to tolerate side effects from medications, such as constipation and dry mouth, which may contribute to low persistence with antimuscarinic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do women with overactive bladder have realistic expectations for therapy? Renganathan, A., Robinson, D., Cardozo, L., et al.[2021]

The study demonstrated that ordered mesoporous silica SBA-15 significantly enhances the controlled release of ketorolac tromethamine, a common pain medication, compared to traditional oral formulations.

Using various characterization techniques, the researchers confirmed the successful adsorption of ketorolac into the SBA-15 silica nanochannels, indicating that this method could improve the therapeutic efficacy of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanostructured SBA-15 host applied in ketorolac tromethamine release system. Cussa, J., Juárez, JM., Gómez Costa, MB., et al.[2018]

In a study of 70 women with overactive bladder (OAB) who did not respond to medication, combining behavioral therapy (BT) and pelvic floor muscle training (PFMT) with drug therapy led to significant improvements in OAB symptoms compared to those receiving only BT and medication.

After 12 weeks, the active therapy group showed a significant reduction in OAB scores and nocturia, with 31.25% of patients reporting being dry, while the control group showed no significant improvement in OAB scores and only 13.3% reported being dry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effectively do we apply first-line treatment in overactive bladder? Alkis, O., Ozlu, A., Kartal, IG., et al.[2022]

In a study of 32 patients undergoing spinal tumor resection and reconstruction, both polymethylmethacrylate (PMMA) and expandable cages (EC) were found to be effective for anterior column reconstruction, with no significant differences in overall survival or estimated blood loss between the two methods.

While there was a trend suggesting better kyphosis reduction with expandable cages compared to PMMA, both methods provided similar functional outcomes and performance status, indicating that either option is viable for stabilizing the spine after tumor removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of polymethylmethacrylate versus expandable cage in anterior vertebral column reconstruction after posterior extracavitary corpectomy in lumbar and thoraco-lumbar metastatic spine tumors. Eleraky, M., Papanastassiou, I., Tran, ND., et al.[2022]

In a study of 54 patients who underwent cervical corpectomy, the use of hollow cylindrical PMMA struts for spinal fusion showed no complications and provided satisfactory clinical results over a follow-up period of at least 2 years.

Significant improvements in neurological status were observed, with the Nurick Scale scores improving from an average of 2.94 to 1.71, indicating effective recovery and spinal stability in the majority of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hollow cylindrical polymethylmethacrylate strut for spinal reconstruction after single-level cervical corpectomy. Chen, JF., Wu, CT., Lee, SC., et al.[2006]

A systematized bladder training program was effective in improving symptoms of idiopathic overactive bladder (OAB) in 85 patients, showing significant reductions in frequency, nocturia, and urgency after the first session.

Patients reported enhanced quality of life and perceived usefulness of bladder training, with improvements noted in various health domains and voiding patterns, indicating that this non-invasive approach could be widely applied in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term Effects of a Systematized Bladder Training Program for Idiopathic Overactive Bladder: A Prospective Study. Lee, HE., Cho, SY., Lee, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04873037

BTL Emsella Chair Versus Sham for the Treatment of ... Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported overactive bladder symptoms as measured by the Overactive Bladder ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026803/

Prospective Comparative Study of EMSella Therapy and ... The results indicate that anterior colporrhaphy is significantly more effective in reducing prolapse and improving bladder function.

3. ctv.veeva.com ctv.veeva.com/study/btl-emsella-chair-versus-sham-for-the-treatment-of-overactive-bladder

BTL Emsella Chair Versus Sham for the Treatment of ... The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment.

4. clinicaltrial.be clinicaltrial.be/en/details/44357?per_page=20&only_recruiting=0&only_eligible=0

BTL Emsella Chair Versus Sham for the Treatment of ... The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10383588/

Evaluation of Possible Side Effects in the Treatment of Urinary ... The effectiveness of treating UI with MS is estimated to be between 29–53% and 86–94% for SUI and between 20–25% and 50–85% for UUI [20]. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6851770/

Safety and Efficacy of a Non‐Invasive High‐Intensity ... This study demonstrated that HIFEM technology can safely and effectively treat stress, urge and mixed urinary incontinence by pelvic floor muscle strengthening.

7. mcgs.bcbsfl.com mcgs.bcbsfl.com/MCG?mcgId=01-97000-06&pv=false

Subject: Pelvic Floor Stimulation as a Treatment of Incontinence ECRI Clinical Evidence Assessment. Emsella Electromagnetic Stimulation System (BTL Industries,. Inc.) for Treating Urinary Incontinence. 2022.