Vulvar Atrophy Clinical Trial
Official title:
Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness
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.
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.
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