Vulvar Atrophy
Conditions
Brief summary
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.
Interventions
DEVICEBtHIntimate® Injectable Hyaluronic Acid Treatment
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.
Sponsors
i+Med S.Coop.
Dr. Goya Análisis, SL.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women (≥18 years). * Women with mild or moderate vulvar atrophy, including deflation or vulvar ptosis, or with visible signs of genital aging, or women seeking aesthetic improvement of the vulvovaginal area, including peri-menopausal or women with genitourinary syndrome of menopause (GSM). * Ability and willingness to comply with all study visits and procedures. * Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires. * For women of childbearing potential: negative pregnancy test and agreement to use reliable contraception during the study (hormonal contraception, IUD/IUS, condoms, diaphragm with spermicide, vasectomized partner, or true abstinence).
Exclusion criteria
* Allergy or hypersensitivity to any component of BtH Intimate 2.0%. * Pregnancy or planned pregnancy, or breastfeeding. * Active infection or pathology in the area to be treated. * Presence of bacterial, fungal, or viral infection in or near the vulvovaginal region, or current treatment for such conditions. * Known tendency to develop hypertrophic scars or keloids. * Signs of inflammation in or near the treatment area, or receiving treatment for inflammation. * History of any vulvovaginal rejuvenation procedure within the last 6 months or during the study (e.g., laser, radiofrequency, electrotherapy, dermal fillers, PRP, etc.). * Unrealistic or disproportionate expectations regarding treatment outcomes. * Incorrectly selected participants (those found retrospectively to fail inclusion or meet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement (GAIS) | Baseline to 12 weeks and 24 weeks | 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. |
| Incidence of Serious Adverse Events (SAEs) | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction (Likert Scale) | Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks | 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. |
| Investigator-Rated Aesthetic Parameters with a Visual Analogue Scale (VAS) | Baseline, 4 weeks, 12 weeks, 24 weeks | 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. |
| Female Sexual Function Index (FSFI) | Baseline, 4 weeks, 12 weeks, 24 weeks | 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. |
| Vulvovaginal Symptoms (VAS) | Baseline, 4 weeks, 12 weeks, 24 weeks | 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. |
| PGI-I (Patient Global Impression of Improvement) | Time Frame: 4 weeks, 12 weeks, 24 weekS | 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). |
| Hydration of Vulvar Tissue (Corneometer®) | Baseline, 4 weeks, 12 weeks, 24 weeks | Hydration of the treated area measured using a Corneometer® biometric probe. Improvement will be calculated relative to baseline values." |
| Non-Serious Adverse Events (AEs) | 6 months | Frequency, severity, duration, and investigator-determined causality of all non-serious adverse events (e.g., erythema, swelling, bruising, palpable nodules). |
| Future Use Questionnaire | 24 weeks | Participant-reported acceptance and willingness to use the product again or recommend it, including purchase intention and perceived effectiveness. |
| Usability Assessment (Investigator) | 24 weeks | Investigator evaluation of device usability, including syringe handling, injection force, ergonomics, packaging, and product flow through the cannula. |
Countries
Spain
Outcome results
None listed