Emsella Chair Therapy for Overactive Bladder

(EmsellaOAB Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kenneth M Peters, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

This trial is testing the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on patients with overactive bladder. These patients often seek non-surgical treatments due to medication side effects. The chair helps by making the pelvic muscles stronger, similar to doing many Kegel exercises.

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 data supports the effectiveness of the Emsella Chair treatment for overactive bladder?

The research highlights that alternative treatments like sacral neuromodulation, which involves stimulating nerves to improve bladder control, have shown significant improvement in bladder function and quality of life for patients with overactive bladder. This suggests that treatments like the Emsella Chair, which also use electromagnetic stimulation, may offer similar benefits. ^{1 2 3 4 5}

How does Emsella Chair Therapy differ from other treatments for overactive bladder?

The Emsella Chair Therapy is unique because it uses high-intensity focused electromagnetic (HIFEM) technology to stimulate pelvic floor muscles, offering a non-invasive and painless treatment option for overactive bladder, unlike traditional treatments that may involve medication or surgery. ^{6 7 8 9 10}

Research Team

Kenneth M Peters, MD

Principal Investigator

Beaumont Hospital-Royal Oak

Eligibility Criteria

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 am 18 years old or older.

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

Trial Timeline

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)

Treatment Details

Interventions

• BTL Emsella Chair (Electromagnetic Technology)
• Sham BTL Emsella Chair (Behavioural Intervention)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Dr. Benjamin Schwartz

William Beaumont Hospitals

Chief Medical Officer since 2021

MD from George Washington University School of Medicine and Health Sciences, Master in Healthcare Management from Harvard University

Tina Freese Decker

William Beaumont Hospitals

Chief Executive Officer since 2022

MBA from Stanford University

Findings from Research

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 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]

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 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]

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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Subjective measures of efficacy and quality of life in overactive bladder syndrome. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Therapy-refractory overactive bladder: alternative treatment approaches]. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Short-term Effects of a Systematized Bladder Training Program for Idiopathic Overactive Bladder: A Prospective Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Do women with overactive bladder have realistic expectations for therapy? [2021]

5. England pubmed.ncbi.nlm.nih.gov

How effectively do we apply first-line treatment in overactive bladder? [2022]

6. China pubmed.ncbi.nlm.nih.gov

Outcomes and cost-minimization analysis of cement spacers versus expandable cages for posterior-only reconstruction of metastatic spine corpectomies. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Nanostructured SBA-15 host applied in ketorolac tromethamine release system. [2018]

8. Germany 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. [2022]

9. Germany 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]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Hollow cylindrical polymethylmethacrylate strut for spinal reconstruction after single-level cervical corpectomy. [2006]