Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dr. Goya Análisis, SL. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This prospective, single-center, before-after study evalutated BtH Intimate 2.0%, a cross-linked hyaluronic acid injectable used to restore volume and improve the aesthetic appearance and hydration of the vulvovaginal area in adult women. Forty participants with mild to moderate vulvar atrophy or genital aging signs received a single treatment, with an optional touch-up at 4 weeks, and were followed for six months. The primary objectives were to measure global aesthetic improvement using the GAIS scale and to assess safety through the recording of serious adverse events. Secondary measures included patient satisfaction, sexual function (FSFI), symptom improvement (VAS), tissue hydration, and overall patient-reported benefit. Expected risks were mild and transient, consistent with HA fillers, while the intervention aimed to enhance comfort, appearance, and quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BtHIntimate® Injectable Hyaluronic Acid Treatment | Experimental | Participants in this single-arm study will receive a single intradermal infiltration of BtH Intimate 2.0% intended to restore volume and improve the aesthetic appearance, hydration, and firmness of the vulvovaginal area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BtHIntimate® Injectable Hyaluronic Acid Treatment | Device | BtHIntimate 2.0% is administered to the labia majora and/or mons pubis according to individual clinical needs. An optional touch-up may be performed at the 4-week follow-up visit if deemed necessary by the investigator. All participants are followed for 6 months, during which aesthetic outcomes, tissue hydration, patient-reported symptoms, sexual function, satisfaction, and safety events are evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement (GAIS) | Aesthetic improvement of the vulvovaginal area assessed by the investigator using the 5-point Global Aesthetic Improvement Scale (GAIS: "very much improved," "much improved," "improved," "no change," "worse"). Clinical relevance is defined as ≥60% of participants rated as "Improved" or better at week 12 or 24. | Baseline to 12 weeks and 24 weeks |
| Incidence of Serious Adverse Events (SAEs) | Number, frequency, severity, and relationship of all serious adverse events recorded according to EU MDR definitions (death, life-threatening events, hospitalization, permanent impairment, or fetal harm). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction (Likert Scale) | A 5 point Likert Scale (Very satisfied, Satisfied, Slightly satisfied, indifferent and unsatisfied). The percentage of very satisfied, satisfied and slightly satisfied answers was taken into account. | Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks |
| Investigator-Rated Aesthetic Parameters with a Visual Analogue Scale (VAS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense Medical Center (Virtus Group) | Madrid | Madrid | 28805 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Clinical assessment of improvement in aesthetic parameters using a visual analogue scale (VAS 0-10): volume, hydration, elasticity, hyperpigmentation, and firmness. Improvement will be calculated as the change in points from baseline. |
| Baseline, 4 weeks, 12 weeks, 24 weeks |
| Female Sexual Function Index (FSFI) | The FSFI consists of 19 multiple-choice questions coded from 0.0 to 5.0. Each score has a specific meaning depending on the item. The scale includes six sexual domains. The maximum score for each domain is 6.0, obtained by summing the item responses and multiplying by a correction factor. The total composite sexual function score is the sum of all domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0. Improvement will be calculated as the change in points from baseline. | Baseline, 4 weeks, 12 weeks, 24 weeks |
| Vulvovaginal Symptoms (VAS) | Vulvovaginal symptoms assessed using a 0-10 visual analogue scale (VAS). The following symptoms are evaluated: itching, friction or rubbing associated with atrophy, dryness, pain, sensitivity, tingling, and dyspareunia. Improvement will be calculated as the change in points from baseline. | Baseline, 4 weeks, 12 weeks, 24 weeks |
| PGI-I (Patient Global Impression of Improvement) | Patient's global impression of improvement using 7-point PGI-I scale (1 = "very much improved" to 7 = "very much worse"). Responders are scores 1 (Very much improved), 2 (Much improved) and 3 (Improved). | Time Frame: 4 weeks, 12 weeks, 24 weekS |
| Hydration of Vulvar Tissue (Corneometer®) | Hydration of the treated area measured using a Corneometer® biometric probe. Improvement will be calculated relative to baseline values." | Baseline, 4 weeks, 12 weeks, 24 weeks |
| Non-Serious Adverse Events (AEs) | Frequency, severity, duration, and investigator-determined causality of all non-serious adverse events (e.g., erythema, swelling, bruising, palpable nodules). | 6 months |
| Future Use Questionnaire | Participant-reported acceptance and willingness to use the product again or recommend it, including purchase intention and perceived effectiveness. | 24 weeks |
| Usability Assessment (Investigator) | Investigator evaluation of device usability, including syringe handling, injection force, ergonomics, packaging, and product flow through the cannula. | 24 weeks |