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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special chair called the BTL Emsella to determine its effectiveness for stress urinary incontinence (SUI), which occurs when activities like coughing, laughing, or exercising cause urine leakage. Researchers aim to compare the chair's effectiveness against a placebo version that lacks its full technology. Individuals who experience urine leakage when coughing or laughing and have not previously tried this chair may be suitable for the trial. Participants should not have metal implants or currently use bladder support devices. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for SUI.

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 prior data suggests that the Emsella chair is safe for treating stress urinary incontinence?

Research has shown that the BTL Emsella chair, which uses a special type of electromagnetic technology, is safe for treating stress urinary incontinence (SUI). Studies have found that this technology effectively strengthens pelvic muscles, reducing SUI symptoms. Importantly, these studies have not reported any major side effects, indicating the treatment is generally well-tolerated. People using the Emsella chair typically do not experience serious side effects, making it a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stress urinary incontinence involve pelvic floor exercises, medications, or surgery. However, the BTL Emsella is unique because it uses High-Intensity Focused Electromagnetic (HIFEM) technology to stimulate pelvic floor muscles without any invasive procedures. This method delivers thousands of contractions in a single session, which could significantly improve muscle strength and bladder control. Researchers are excited about BTL Emsella because it offers a non-invasive alternative with the potential for quicker, more convenient results compared to traditional therapies.

What evidence suggests that the Emsella Chair is effective for stress urinary incontinence?

Research has shown that the BTL Emsella chair, which uses focused electromagnetic waves, effectively treats stress urinary incontinence (SUI). Studies have found that this technology strengthens pelvic muscles, reducing urinary incontinence symptoms. In one study, patients experienced significant improvement, with urine leakage decreasing from about four pads to less than one pad over six months. This trial will compare the Emsella Chair Active Treatment with the Emsella Sham Treatment to further evaluate its effectiveness. Overall, evidence indicates that the Emsella chair can significantly benefit those dealing with this condition. ^{1 2 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8016513/

A Comparative Study on the Effects of High-Intensity ... BTL EMSELLA uses HIFEM technology for PFM strengthening and reduction of UI. ... HIFEM technology a new perspective in treatment of stress urinary incontinence.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03877640

Study Details | NCT03877640 | Urinary Stress Incontinence ... The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment ...

3. 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.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/91/NCT04248491/Prot_SAP_000.pdf

A Single-Blind, Randomized Study of the BTL Emsella™ ... The limited number of studies on this HIFEM technology have focused on its effects on stress, urge, and mixed urinary incontinence as well as quality of life.

5. mdpi.com mdpi.com/2227-9059/12/12/2883

Effect of High-Intensity Focused Electromagnetic ... Results: HIFEM treatment significantly improved SUI symptoms on pad tests from 4.2 ± 5.5 to 0.6 ± 1.3 and patients' self-assessment in the 6-month follow-up.

6. journals.lww.com journals.lww.com/fpmrs/fulltext/2021/04000/a_comparative_study_on_the_effects_of.11.aspx

A Comparative Study on the Effects of High-Intensity Focused BTL EMSELLA uses HIFEM technology for PFM strengthening and reduction of UI. ... HIFEM technology a new perspective in treatment of stress urinary incontinence.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04133675/btl-emsella-chair-versus-sham-for-the-treatment-of-stress-urinary-incontinence

BTL Emsella Chair Versus Sham for the Treatment of ... This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.