BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-60
SponsorBTL Industries Ltd.

About this trial

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 to improve depressive symptoms and urinary incontinence in women who delivered a healthy, singleton infant 2-60 months before enrollment in the study and are aged 22 years and older, but under the age of 60 years. The main question it aims to answer is: Does the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to:

Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Edinburgh Postnatal Depression Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen Version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire

Eligibility criteria

Qualifiers

Delivery of a healthy, singleton infant 2-60 months before enrollment in the study

Current involvement in caregiving or regular contact with the child in question

Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5

Age ≥ 22, but ≤ 60 years

Disqualifiers

Metallic objects in or near the head

rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil*

Implanted stimulator devices, implanted defibrillators, implanted neurostimulators

Cardiac pacemakers

Trial design

Treatments tested in this trial

  • EXOMIND (BTL-699-2) ActiveTreatment
  • EMSELLA (HPM-6000UF) ActiveTreatment
  • EXOMIND (BTL-699-2) Sham Treatment
  • EMSELLA (HPM-6000UF) Sham Treatment

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators