BTL Emsella for Stress Urinary Incontinence

Recruiting at 1 trial location

Overseen By Julie Swanson, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Must be taking: Anticholinergics, Tricyclic antidepressants

Disqualifiers: Morbid obesity, Pulmonary insufficiency, Neurogenic incontinence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if the Emsella chair, which uses electromagnetic waves to strengthen pelvic muscles, is effective for people with stress urinary incontinence. The goal is to see if this treatment can reduce urine leakage during activities like exercise or laughing. This new technology is used for pelvic muscle strengthening for the treatment of stress urinary incontinence.

Will I have to stop taking my current medications?

You won't have to stop taking your current medications, but you must keep the dose stable if they affect urinary function. You also can't start any new treatments during the trial.

What data supports the effectiveness of the treatment BTL Emsella for stress urinary incontinence?

Research suggests that extracorporeal magnetic stimulation (EMS), which is similar to the technology used in the BTL Emsella chair, is a non-invasive, effective, and safe treatment for stress urinary incontinence. This indicates that the BTL Emsella chair, which uses high-intensity focused electromagnetic (HIFEM) technology, may also be effective for this condition. ^{1 2 3 4 5}

Is BTL Emsella safe for treating stress urinary incontinence?

Extracorporeal magnetic stimulation (EMS), which is similar to BTL Emsella, is considered a safe and non-invasive treatment for stress urinary incontinence. ^{1 2 5 6 7}

How does the BTL Emsella treatment for stress urinary incontinence differ from other treatments?

BTL Emsella is unique because it uses High-Intensity Focused Electromagnetic (HIFEM) technology to stimulate pelvic floor muscles, which is a non-invasive approach compared to surgical options like slings or inlays. This treatment allows patients to remain fully clothed during sessions, making it more convenient and less invasive than traditional surgical methods. ^{1 5 8 9 10}

Research Team

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Eligibility Criteria

This trial is for men and women aged 18-80 with stress urinary incontinence, who can consent to the study's requirements. Participants must not start new treatments or change current medication doses during the study. Women using bladder support devices or of childbearing age must follow specific guidelines, while men should be post-prostatectomy.

Inclusion Criteria

You have a cough or bladder problem that shows up during a test.

I agree to not use any bladder support devices during the study.

I agree to keep my bladder-related medication doses constant during the study.

Exclusion Criteria

I am not pregnant and do not plan to become pregnant during the study.

My BMI is 40 or higher.

I have a piercing between my waist and knees and won't remove it for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electromagnetic perineal stimulation using the Emsella chair or sham treatment, with 8 sessions over 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of urinary incontinence and sexual function

8 weeks

Treatment Details

Interventions

• BTL Emsella
• Sham BTL Emsella

Trial Overview The trial tests the Emsella chair against a sham (fake treatment) to see if electromagnetic technology helps treat involuntary urine leakage caused by pressure from activities like coughing or laughing.

Participant Groups

Group I: Emsella Chair Active Treatment Active Control 1 Intervention

Active treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. 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 then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Group II: Emsella Sham Treatment Placebo Group 1 Intervention

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

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

Approved in United States as BTL Emsella Chair for:

• Stress Urinary Incontinence (SUI) in men and women

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Findings from Research

In a study of 70 patients with stress urinary incontinence (SUI) treated with the Remeex® Adjustable BSU, the success rates for achieving continence were high, with 90% in patients with recurrent incontinence and 92% in those without prior surgeries.

Postoperative complications were mostly mild (Clavien II), including urinary tract infections and transient urinary retention, with no significant differences between groups, indicating that the Remeex® BSU is a safe option for treating SUI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of female recurrent or not stress urinary incontinence with intrinsic sphincter deficiency: Sub-urethral retropubic adjustable sling (Remeex)]. Flochlay, M., Bey, E., Bruneaux, E., et al.[2022]

Pelvic floor muscle training (PFMT) is recognized as the first-line conservative treatment for stress urinary incontinence (SUI), while extracorporeal magnetic stimulation (EMS) is a safe and effective non-invasive alternative.

A new randomized controlled trial will directly compare the effectiveness of PFMT and EMS in women with SUI, aiming to determine which treatment offers better clinical outcomes over an eight-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of extracorporeal magnetic innervation and Kegel exercises for stress urinary incontinence in adult women: study protocol for a randomized controlled trial. Mikuš, M., Fišter, K., Škegro, B., et al.[2022]

The ohmmeter was effective in identifying the site of fluid leaks in 90% of cases during revision surgery for the AMS 800 artificial urinary sphincter, which is crucial for targeted repairs.

In 17 cases where only the malfunctioning component was replaced based on the ohmmeter's findings, all patients achieved satisfactory outcomes, indicating the method's reliability and potential to reduce the need for repeat surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ohmmeter Identifies the Site of Fluid Leakage during Artificial Urinary Sphincter Revision Surgery. Selph, JP., Belsante, MJ., Gupta, S., et al.[2015]

The new electromechanical artificial urinary sphincter (emAUS) demonstrated effective continence in an animal model, with bladder leak point pressures indicating strong performance during device activation.

Histopathological evaluations showed no significant damage to the urethra or surrounding tissues after 3 months, suggesting that the emAUS may avoid vascular damage, although further long-term studies are necessary before clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental evaluation of an electromechanical artificial urinary sphincter in an animal model. Valerio, M., Jichlinski, P., Dahlem, R., et al.[2019]

The REMEEX system for treating stress urinary incontinence (SUI) showed similar objective cure rates across normal weight, overweight, and obese women, with 42.3% to 51.6% achieving cure after 3 months, indicating its effectiveness regardless of body weight.

Patient satisfaction was high across all groups, with over 91% reporting satisfaction one year post-surgery, demonstrating that the REMEEX procedure is a reliable option for women with SUI and intrinsic sphincter deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readjustable midurethral sling (REMEEX system) in obese women. Kim, WB., Lee, SW., Lee, KW., et al.[2020]

In a study of 50 women with recurrent stress urinary incontinence, the adjustable Remeex system™ showed a high objective cure rate of 90%, indicating its efficacy in treating this condition.

While the subjective cure rate was lower at 48%, the procedure significantly improved patients' quality of life, with a notable reduction in urinary incontinence impact from a median score of 10 to 2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency. Plata, M., Robledo, D., Bravo-Balado, A., et al.[2019]

The Remeex system, a readjustable midurethral sling, was found to be effective and safe for treating stress urinary incontinence in women, including those with female voiding dysfunction, based on a study of 102 patients.

There were no significant differences in surgical outcomes or complication rates between women with and without voiding dysfunction, indicating that the Remeex system can be used effectively across different patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a readjustable midurethral sling (Remeex system) for stress urinary incontinence with female voiding dysfunction. Chung, JW., Yoo, ES.[2019]

In a study involving 82 patients treated with a butterfly-shaped mesh for stress urinary incontinence (SUI), 74 patients were completely cured and 2 showed improvement after follow-up, indicating high efficacy of the procedure.

The procedure was performed under local anesthesia with minimal complications, as no cases of urine retention, infection, or bladder dysfunction were reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical research of a butterfly shaped mesh in the treatment of stress urinary incontinence]. Fan, BZ., Xia, H., Chen, XL., et al.[2005]

In a clinical trial with 97 women suffering from stress urinary incontinence (SUI), the Efemia Bladder Support device led to a significant 55% reduction in total urine leakage compared to standard care, with a 67% reduction during provocation tests like coughing and jumping.

The device was found to be safe and well-tolerated, with no serious adverse events reported, and 74% of participants in postmarket studies expressed a likelihood to continue using Efemia, especially during physical activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies. Jonasson, AF., Bryder, K., Sthengel, E.[2021]

The male Remeex system (MRS) effectively treated postprostatectomy stress urinary incontinence in 24 men, with 91.7% remaining continent after surgery and significant improvement in quality of life as indicated by a drop in the Incontinence Impact Questionnaire score from 79 to 11 after 6 months.

The updated MRS-II version appears to reduce the need for mesh adjustments, indicating potential improvements in the device's design and effectiveness, while maintaining a low complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up for the treatment of male urinary incontinence with the Remeex system. Navalón-Monllor, V., Ordoño-Domínguez, F., Pallás-Costa, Y., et al.[2017]

References

1. France pubmed.ncbi.nlm.nih.gov

[Treatment of female recurrent or not stress urinary incontinence with intrinsic sphincter deficiency: Sub-urethral retropubic adjustable sling (Remeex)]. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of extracorporeal magnetic innervation and Kegel exercises for stress urinary incontinence in adult women: study protocol for a randomized controlled trial. [2022]

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

The Ohmmeter Identifies the Site of Fluid Leakage during Artificial Urinary Sphincter Revision Surgery. [2015]

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

Experimental evaluation of an electromechanical artificial urinary sphincter in an animal model. [2019]

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

Readjustable midurethral sling (REMEEX system) in obese women. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency. [2019]

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

Efficacy and safety of a readjustable midurethral sling (Remeex system) for stress urinary incontinence with female voiding dysfunction. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Clinical research of a butterfly shaped mesh in the treatment of stress urinary incontinence]. [2005]

9. Egypt pubmed.ncbi.nlm.nih.gov

A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

Long-term follow-up for the treatment of male urinary incontinence with the Remeex system. [2017]