An interventional study of Treatment with BTL-785F and HPM-6000UF Devices in Vulvovaginal Atrophy, Urinary Incontinence and Sexual Dysfunction, sponsored by BTL Industries Ltd.. Completed at 2 sites in United States. Open to female participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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:
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 25 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subjects will undergo six treatment sessions.
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.
Assessment of Change in Quality of Life of Women with Vulvovaginal Atrophy Symptoms
The change in the score obtained from the Vulvovaginal Symptoms Questionnaire will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. The score ranges from 0 to 16 for sexually inactive women and from 0 to 20 for sexually active women. An improvement is defined as a decrease in score.
Time frame: 12 months
Assessment of Change in Quality of Life of Women with Urinary Incontinence
The change in the score obtained from the King's Health Questionnaire will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. The score ranges between 0 to 100 for the nine domains, and between 0 to 30 for the Symptom Severity Scale. An improvement is defined as a decrease in score.
Time frame: 12 months
Assessment of Change in Sexual Functioning
The change in the score obtained from the 6-item Female Sexual Function Index will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. The score ranges between 0 to 30. An improvement is defined as an increase in score.
Time frame: 12 months
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Pain Rating Scale (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Pain Rating Scale indicate higher therapy comfort.
Time frame: 12 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subject Satisfaction questionnaire. The questionnaire will be administered after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. Responses to questions about the treated urogenital area will range from "strongly agree" (1 point) to "strongly disagree" (5 points). A higher score for each statement indicate better outcomes.
Time frame: 12 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the combined application of the BTL-785F and HPM-6000UF devices and to identify side effects and adverse events associated with the study treatment.
Time frame: 12 months
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.