NCT06846216

Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness

Evaluation of the Combined Application of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the combined application of BTL-785F and HPM-6000UF Devices in improving quality of life in women with negative changes in the urogenital system (vulvovaginal atrophy symptoms, urinary incontinence or sexual dysfunction). The main question it aims to answer is: Does the combined application of BTL-785F and HPM-6000UF Devices reduces the score of the Vulvovaginal Symptoms Questionnaire? Participants will: * Undergo 6 treatment sessions.Three sessions will consist of combined application of BTL-785F and HPM-6000UF devices and three sessions will consist of standalone application of the HPM-6000UF device. * Attend follow-up visits * Complete questionnaires

Detailed description

This study will evaluate the clinical efficacy and performance of the combined application of the BTL-785F and HPM-6000UF devices for the improvement of Quality of Life in Women with in the urogenital system (vulvovaginal atrophy symptoms, urinary incontinence or sexual dysfunction). This clinical trial uses a multicenter, single-arm, open-label, interventional design. Subjects will undergo six treatment sessions. Follow-up visits are scheduled 1 month, 3 months, and 6 months after the last treatment session. Participants will complete the Vulvovaginal Symptoms Questionnaire, King's Health Questionnaire, and the 6-item Female Sexual Function Questionnaire, which will be administered at the baseline visit, after the last treatment, and all follow-up visits. Additionally, the Subject Satisfaction Questionnaire, given after the last treatment and at all follow-up visits, will be filled out. Therapy Comfort Questionnaire will be administered after the last treatment. During the study duration, observation for adverse events and side effects will take place.

Conditions

• Vulvovaginal Atrophy
• Urinary Incontinence
• Sexual Dysfunction

Interventions

Type	Name	Description
DEVICE	Treatment with BTL-785F and HPM-6000UF Devices	Three treatment sessions will consist of the consecutive application of the BTL-785F and HPM-6000UF devices, delivered 5-10 days apart. Three sessions will consist of the standalone application of the HPM-6000UF device, delivered 2-4 days apart. The treatments with BTL-785 device equipped with BTL-785-3 applicator will last 2-10 minutes and with HPM-6000UF 28 minutes.

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study