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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with BTL-785F and HPM-6000UF Devices | Experimental | Subjects will undergo six treatment sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with BTL-785F and HPM-6000UF Devices | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pelvic Health and Wellness | Mission Viejo | California | 92691 | United States | ||
| Kimberly L. Evans MD, PLLC |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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. | 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. | 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. | 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. | 12 months |
| Sugar Land |
| Texas |
| 77478 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |