EXOMIND + EMSELLA for Depression and Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments, EXOMIND and EMSELLA (both therapeutic devices), to determine their effectiveness in improving depression and urinary incontinence in perimenopausal or postmenopausal women. The researchers aim to discover if using these devices together can reduce depressive symptoms and enhance sexual function. Women who have experienced 12 months without periods (menopause) or have had long gaps between periods (perimenopause) and show symptoms of depression may be suitable for this study. Participants will undergo twelve treatments and complete several questionnaires to monitor their progress. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve treatment options for women with these conditions.
What prior data suggests that the EXOMIND and EMSELLA devices are safe for treating depression and urinary incontinence?
Research has shown that both the EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) treatments are safe.
For EMSELLA, studies have found this non-invasive treatment to be very safe for urinary incontinence. Side effects are rare and usually mild. This device uses electromagnetic waves to strengthen pelvic floor muscles, similar to Kegel exercises. Importantly, EMSELLA is FDA-approved for treating urinary incontinence, indicating it has passed strict safety tests.
EXOMIND is also well-tolerated. This device provides non-invasive brain stimulation to improve mental well-being. It is FDA-cleared for treating depression, meeting high safety standards. Research supports its safety, even at full intensity, with no significant adverse effects reported.
In summary, both the EXOMIND and EMSELLA devices are considered safe based on existing studies and FDA approvals. While participating in any clinical trial involves some risk, these treatments have shown a favorable safety profile in past research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of EMSELLA and EXOMIND for treating depression and urinary incontinence because this approach leverages innovative technologies that differ from current treatments. Unlike standard options for depression, which often include medications like SSRIs or therapy, EXOMIND utilizes a unique neuromodulation technique to potentially enhance brain function. For urinary incontinence, instead of relying on pelvic floor exercises or surgery, EMSELLA uses high-intensity focused electromagnetic (HIFEM) technology to strengthen pelvic floor muscles non-invasively. This combination could offer a novel, non-invasive solution that addresses both conditions simultaneously, potentially improving patient outcomes and convenience.
What evidence suggests that the EXOMIND and EMSELLA devices could be effective for depression and urinary incontinence?
Research has shown that EMSELLA, which uses focused electromagnetic energy, is a safe and effective treatment for urinary incontinence. Studies report a noticeable decrease in urine leaks, from about 2 to less than 1 per day, and an improvement in quality of life scores from 70.3 to 84.8. Additionally, the FDA has approved EXOMIND for treating depression. Clinical studies have demonstrated consistent improvements in mental health, reducing symptoms like anxiety and brain fog. In this trial, participants will receive either active treatment with both EMSELLA and EXOMIND or a sham treatment. Both devices show promise individually, and using them together might enhance benefits for both depression and urinary incontinence.25678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo twelve treatments with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EMSELLA (HPM-6000UF)
- EXOMIND (BTL-699-2)
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)
Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)
Find a Clinic Near You
Who Is Running the Clinical Trial?
BTL Industries Ltd.
Lead Sponsor
Citations
Prospective Comparative Study of EMSella Therapy and ...
The results indicate that anterior colporrhaphy is significantly more effective in reducing prolapse and improving bladder function. Surgically ...
BTL-699-2 and HPM-6000UF Devices for the Improvement ...
The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able ...
Effects of High-Intensity Focused Electromagnetic Therapy ...
These findings support progression to a definitive trial: both interventions improved quality of life and bladder control, and the combination of HIFEM and PFMT ...
PD39-14 A SINGLE INSTITUTION EXPERIENCE WITH ...
The average Global Improvement Score was 3 (mild improvement; range 1-5) on a 7-point Likert scale. CONCLUSIONS: Emsella appeared to have mixed ...
5.
bethanyhansenpt.com
bethanyhansenpt.com/blog/does-the-emsella-chair-really-work-for-urinary-incontinenceDoes the Emsella Chair Really Work for Urinary ...
Improvement, on average, was going from self-reported 1.84 leaks/day to 0.58 leaks per day, increased quality of life score from 70.3 to 84.8, ...
Safety and Efficacy of a Non‐Invasive High‐Intensity Focused ...
This study demonstrated that HIFEM technology can safely and effectively treat stress, urge and mixed urinary incontinence by pelvic floor muscle strengthening.
Emsella Chair Side Effects: What to Expect
Studies on magnetic stimulation for incontinence confirm that it's a very safe treatment, with side effects being both rare and mild when they ...
Evaluation of Possible Side Effects in the Treatment of Urinary ...
Magnetic stimulation is a type of conservative treatment of urinary incontinence. Our aim was to evaluate the possible side effects of this method.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.