Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index
研究概览
简要总结
Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
- •Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
- •English-speaking
- •Willingness and able to comply with the study requirements
排除标准
- •Symptomatic pelvic organ prolapse protruding beyond the hymen)
- •History of prior vaginal mesh or midurethral mesh sling surgery
- •History of pelvic radiation or genital tract malignancy
- •Current symptomatic pelvic organ prolapse (stage II or greater)
- •Active vulvar dermatoses or genitourinary infection
- •Unable to hold anticoagulation
- •Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation
- •Pregnancy or pre-menopausal status
结局指标
主要结局
Female Sexual Function Index
时间窗: Assessed at baseline and at 6 weeks and 6 months post-procedure
Validated questionnaire to assess domains of sexual function with range from 2 to 36 with lower score indicating worse sexual functioning (diagnostic for sexual dysfunction if score is less than or equal to 26.55)
次要结局
- Patient Global Impression of Improvement (PGI-I)(Assessed at 6 weeks and 6 months post-intervention)
- Visual analog scale for vaginal dryness (VAS)(Assessed at 6 weeks and 6 months post-intervention)
- Urinary Distress Inventory (short form) (UDI-6)(Assessed at baseline and 6 weeks/6 months post-intervention)