Comparison Between Platelet-rich Plasma (PRP) and Hyaluronic Acid (HA) in the Treatment of Cancer-therapy Related Vulvovaginal Atrophy and Its Impact on Sexual Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Vulvovaginal atrophy vaginal dryness severity scores
研究概览
简要总结
The goal of this clinical trial is to:
- evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy.
- To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners.
Patients will be divided randomly into 3 groups:
Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid.
Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.
详细描述
-
The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17)
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The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between.
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3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months.
Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment.
- Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale.
Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No). 2. For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy. 3. Assessment of sexual satisfaction of both male and female partners:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia)
- •Patients with vaginal health index <
- •All patients have already finished cancer therapy or are on anti-estrogen treatment.
- •Married sexually active
- •Patients who are not receiving any VVA treatment for at least 30 days before starting therapy.
排除标准
- •Active or recent history of vulvovaginal inflammation or infection
- •History of vulvar or vaginal cancer.
- •Suspicious lesion in the vulvovaginal area on the gynecological examination
结局指标
主要结局
Vulvovaginal atrophy vaginal dryness severity scores
时间窗: 3 months follow up
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy dyspareunia severity scores
时间窗: 3 months follow up
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vaginal health index total score
时间窗: 3 months follow up
scores range from 5-25 with lower scores signifying greater atrophy
次要结局
未报告次要终点
研究者
Salma samir
As. Prof
Alexandria University