EXOMIND + EMSELLA for Postpartum Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether two devices, EXOMIND and EMSELLA, can improve postpartum depression and urinary incontinence in women who have given birth to one healthy baby in the last 2-60 months. The trial compares active treatments to a sham (inactive) treatment to assess the effectiveness of these devices. It suits women who regularly care for their child and experience depression symptoms, such as feeling down or losing interest in activities. Participants will undergo twelve treatment sessions and complete several questionnaires about their health and well-being. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance postpartum recovery.
What prior data suggests that the EXOMIND and EMSELLA devices are safe for postpartum women?
Research has shown that EMSELLA, a device for treating urinary incontinence, is generally well-tolerated and has fewer side effects than surgery. The FDA has approved it for this condition, confirming it has passed strict safety tests.
Similarly, EXOMIND treats major depressive disorder and has also received FDA clearance, indicating its safety for use. Early studies suggest that EXOMIND has few side effects and is usually well-tolerated.
Both EMSELLA and EXOMIND have demonstrated promising safety in their respective uses, making them potential options for those considering joining clinical trials.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for postpartum depression, which often involve antidepressants or psychotherapy, EXOMIND and EMSELLA offer a novel approach. EXOMIND uses advanced neuromodulation to potentially alter brain activity associated with mood regulation, providing a non-invasive option. Meanwhile, EMSELLA employs high-intensity electromagnetic fields to stimulate pelvic floor muscles, which might improve mood by enhancing physical recovery postpartum. Researchers are excited about this combination because it targets both mental and physical aspects of postpartum recovery, offering a holistic approach that could work faster and with fewer side effects than traditional methods.
What evidence suggests that the EXOMIND and EMSELLA devices are effective for postpartum depression and urinary incontinence?
This trial will evaluate the effectiveness of EMSELLA and EXOMIND for postpartum depression. Studies have shown that EMSELLA can significantly improve urinary incontinence, with patients reporting a reduction in daily leaks from 1.84 to 0.58, and 95% experiencing a better quality of life. For EXOMIND, research indicates that 50% of patients notice fewer depressive symptoms within four weeks, and 30-40% experience remission, meaning their symptoms significantly lessen or disappear. Both treatments show promising results for their respective conditions: urinary incontinence and postpartum depression. Participants in this trial will receive either active or sham treatment with both EMSELLA and EXOMIND.12367
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion 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
BTL-699-2 and HPM-6000UF Devices for the Improvement ...
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3.
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, ...
Emsella Review By A Pelvic Floor PT
They found improved contractile abilities, however they only test muscle contraction with participants on their backs. They did find some ...
5.
journals.lww.com
journals.lww.com/fpmrs/fulltext/2021/04000/a_comparative_study_on_the_effects_of.11.aspxA Comparative Study on the Effects of High-Intensity...
This study compares the immediate efficiency of high-intensity focused electromagnetic (HIFEM) therapy and electrostimulation for the treatment of weakened ...
Emsella Contraindications: What You Need to Know
Emsella is FDA-approved for the treatment of urinary incontinence in women, a designation that confirms it has been rigorously tested and ...
Safety and Efficacy of a Non‐Invasive High‐Intensity ...
The aim of this study was to objectively evaluate the efficacy and safety of the BTL EMSELLA device (BTL Industries Inc., Boston, MA) utilizing ...
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