Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Regen Lab SA
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Vaginal pH
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Vaginal pH
时间窗: 3 months
Variation of the vaginal pH between baseline and Month 3 after treatment
Friedmann score
时间窗: 3 months
Variation of the Friedmann score between baseline and Month 3 after treatment
次要结局
- Female Sexual Distress (FSD) score(Month 1, Month 3 and Month 6)
- Adverse device effects(Month 1, Month 3 and Month 6)
- Female Sexual Function Index (FSFI) score(Month 1, Month 3 and Month 6)