BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
This research study is for women aged 40 and over who are going through perimenopause (changes leading to menopause) or have already been through menopause. The study is investigating whether two medical devices, called EXOMIND and EMSELLA, used together, can help improve common issues like low mood (depressive symptoms) and problems with sexual function. It also aims to see if the treatment helps with urinary leakage. Participants will receive twelve treatment sessions, either the active treatment or a ‘sham’ (inactive) version. Researchers will track changes in symptoms and well-being over approximately five months.
At a glance
What is this study about?
This study is designed for women who are experiencing a time of change called perimenopause, or who have already reached menopause. These are natural stages in a woman's life, usually happening around age 40 and beyond. During this time, many women can experience various symptoms, and this study is specifically looking at how two common groups of symptoms – low mood or feelings of sadness, and difficulties with sexual function – might be helped by a new combination of treatments.
The main goal of the study is to test if using two specific medical devices together, known as EXOMIND and EMSELLA, can make a difference. The researchers want to find out if this combined treatment can improve these depressive symptoms and sexual function. They're also interested in seeing if it helps with urinary incontinence, which is a common problem where women unintentionally leak urine.
To find this out, some women will receive the active treatment, while others will receive a 'sham' treatment. A sham treatment is like a dummy treatment that looks and feels similar to the real one but isn't active. This helps the researchers accurately compare the effects of the active treatment. By participating, you would be helping medical science understand better ways to support women during and after menopause.
Key takeaways
- Targets women aged 40+ in perimenopause or postmenopause.
- Investigates two devices (EXOMIND, EMSELLA) for low mood and sexual difficulties.
- Aims to also see effects on bladder issues (urinary incontinence).
- Involves 12 treatment sessions and several questionnaires over ~5 months.
- Some participants will get active treatment, others a non-active 'sham' treatment.
Who may be eligible?
This study is looking for women who are at least 40 years old. You might be eligible if you are going through perimenopause (having infrequent periods for at least 60 days without other medical reasons) or have fully reached menopause (no periods for 12 straight months without other medical reasons). You would also need to be experiencing some low mood, specifically with a score of 5 or more on a common questionnaire called the PHQ-9.
There are also some important things that would prevent you from joining. For example, if you have any metal objects or electronic devices implanted in or near your head, such as a pacemaker, certain types of implants like deep brain stimulators or cochlear implants, or even particular kinds of metal in your head. This is because one of the treatment devices uses magnetic pulses.
Otherwise, you should be willing to attend all appointments, use contraception if you could still get pregnant, and keep any existing medications for mood or sexual function stable for at least a month before the study begins. The team will do a physical check to see if you can receive the treatment safely.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman aged 40 or older?
- Have you had no periods for 12 months (menopause) or very irregular periods for 60+ days (perimenopause)?
- Do you experience symptoms of low mood (a PHQ-9 score of 5 or more)?
- Do you have no metal implants or electronic devices in or near your head?
- Are you able and willing to attend all study appointments?
What does participation involve?
If you decide to join this study, your participation would last for about five months. This involves coming to the clinic for twelve treatment sessions. During these sessions, you would receive treatment from both the EXOMIND and EMSELLA devices. Some participants will receive the active version of these treatments, while others will receive a 'sham' (inactive) version to allow for accurate comparison. You won't know which one you are getting.
Throughout the study, you'll be asked to complete several questionnaires. These questionnaires help the research team understand how your mood, sexual function, physical well-being, and overall comfort with the treatment are changing. You'll complete some of these before your first treatment, some during your treatments, and others after your final treatment session. There will also be two follow-up visits, one month and three months after your last treatment, to see how you are doing in the longer term. If you're using any medications for your mood or sexual health, you'll need to keep them at the same dose you were on before the study started, unless your doctor advises otherwise.
Potential risks and benefits
Locations (3)
- Luxury Psychiatry ClinicVerified postcodeWinter Garden, United States· Recruiting
- Aesthetic + Mind MDVerified postcodeWellesley, United States· Recruiting
- Vitality MD IncVerified postcodeToronto, Canada· Recruiting
Common questions
What is 'perimenopause'?
Perimenopause refers to the time leading up to menopause, when your body starts making less of certain hormones, and your periods become less regular.
What does 'sham treatment' mean?
A sham treatment looks and feels like the real treatment but isn't active. It helps researchers compare the true effect of the active treatment.
How long will I need to be involved in the study?
If you join, your involvement in the study will last for about five months in total.
Will I know if I'm getting the active or sham treatment?
No, you won't know whether you're receiving the active treatment or the sham treatment. This is to ensure the study results are accurate.
Can I continue taking my current medications?
Yes, if you are already on medications for mood or sexual function, you will generally continue them at a stable dose throughout the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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