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

Conditions

• Depressive Symptoms
• Urinary Incontinence

Eligibility Criteria

Sex

FEMALE

Age

22 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• EXOMIND (BTL-699-2) ActiveTreatment — DEVICE
  Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
• EMSELLA (HPM-6000UF) ActiveTreatment — DEVICE
  Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be adjusted according to the subject's feedback, up to 100%. The treatments will be spaced 3 - 7 days apart.
• EXOMIND (BTL-699-2) Sham Treatment — DEVICE
  Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 1% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
• EMSELLA (HPM-6000UF) Sham Treatment — DEVICE
  Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be set to 1%. The treatments will be spaced 3 - 7 days apart.

Study Details

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

Key Dates

Start date

Nov 25, 2025

Status verified

Dec 2025

Primary completion

Dec 11, 2026

Completion

Dec 11, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active treatment with BTL-699-2 and HPM-6000UF
  Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)
• Sham Comparator: Sham treatment with BTL-699-2 and HPM-6000UF
  Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)

Primary Outcome Measure

Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth [ Time Frame: 15 months ]

Locations (3)

Find similar trials in Garfield Heights, OH

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