Vulvar Atrophy
Conditions
Keywords
Vulvovaginal dryness
Brief summary
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia. This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.
Detailed description
A treatment relying on the association of both platelet-rich plasma (PRP) and hyaluronic acid (HA) could represent a therapeutical alternative for patients suffering from vulvovaginal dryness who cannot be treated with hormone therapy. Indeed, hyaluronic acid is widely distributed in all tissues, and most particularly in vulvovaginal tissues. Due to its hydrating and healing properties, HA plays a key role in tissue regeneration, facilitating the entry of a large number and variety of cells into the injured area, reconstructing in this way an extracellular matrix capable of supporting the proliferation and differentiation of cells for tissue regeneration. In addition,its ability to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration of the skin. Thus, the gynaecological use of HA could be a promising therapeutic option for the treatment of vulvovaginal dryness. On the other hand, numerous studies have shown the role of PRP in the healing of soft and hard tissues. PRP is an autologous preparation from the patient's own blood playing the role of growth factors reservoir during treatment. Indeed, platelet activation induces alpha-granules degranulation, releasing synthesized pre-packaged growth factors. Once released, growth factors induce different cell signaling cascades that activate angiogenesis, cell proliferation, cell differentiation and new matrix synthesis for tissue regeneration. A recent clinical study showed that PRP could significantly reduce sexual distress of patients suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and physiologic responsivness in patients with vaginal atrophy. In the present pilot study, a combination of PRP/HA obtained with Cellular Matrix will be injected in the vulva, vaginal wall and perineum of women with vulvovaginal dryness. Outcomes will be compared before and at various timepoints after treatment.
Interventions
DEVICECellular Matrix BCT-HA Kit
Submucosal injections in the vulva, in the posterior vaginal wall and in the perineum of a combination product made of PRP and HA prepared using the Cellular Matrix BCT-HA medical device
Sponsors
Regen Lab SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
case-series
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy * Patients having signed an Informed Consent * Patient capable of understanding the study's imperatives
Exclusion criteria
* Vulvovaginal inflammation or infection * History of vaginal herpes * History of vulvar, vaginal or cervical cancer * Lichen sclerosus * History of allergy to HA * Hereditary or acquired hematological or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (150'000 platelets/µl) * Anemia (HGB ≤ 10g/dl) * Autoimmune disease (Hashimoto, rheumatoid disease, lupus, etc.) * HIV positive * Hepatitis B or C * Pregnancy or breastfeeding * No contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal pH | 3 months | Variation of the vaginal pH between baseline and Month 3 after treatment |
| Friedmann score | 3 months | Variation of the Friedmann score between baseline and Month 3 after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Distress (FSD) score | Month 1, Month 3 and Month 6 | Variation of the FSD score between baseline and various timepoints after treatment |
| Female Sexual Function Index (FSFI) score | Month 1, Month 3 and Month 6 | Variation of the FSFI score between baseline and various timepoints after treatment |
| Adverse device effects | Month 1, Month 3 and Month 6 | Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6 |
Countries
France
Outcome results
None listed