A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS).
研究概览
简要总结
This study is designed to compare the efficacy, acceptability, and safety of vaginal estrogen cream and platelet-rich plasma in pt. complaining of atrophic vaginitis.
详细描述
Oestrogen deficiency affects many organs such as the genitourinary system. Genitourinary involvement causes untoward symptoms of atrophic vaginitis including dryness, burning, dyspareunia, vulvar pruritus, and discharge For this reason, many investigations have been performed to find out effective, safe, and acceptable therapeutic methods for atrophic vaginitis. Although systemic administration of estrogen can improve the localized symptoms of atrophic vaginitis, women are often reluctant to use systemic hormone replacement therapy and prefer local administration of estrogen. Vaginal application of estrogen has been considered an effective treatment of atrophic vaginitis.
The effects of PRP treatment have been evaluated in many clinical conditions, including wound healing, hair repair, skin regeneration [9], vulvar lichen sclerosis, stress urinary incontinence, episiotomy scars, and lubrication aging in the vagina. It can take at least 12 weeks to determine the final effects of treatment with PRP Population of Study It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt
Methodology in detail:
Patients of the first group will receive vaginal estrogen cream one tube every night for 14 nights; then, one tube 2 nights in 1 week (two tubes every week) for 10 weeks.
The second group will receive PRP injection every 3 weeks for 4 times. PRP will be administered to the anterior vaginal wall using 27-G needles once every 3 weeks for 4 times and PRP is mainly injected into the clitoris or the anterior wall of the vagina to increase the tactile sensitivity of the injection site.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women aged 50-70 years old
- •with a clinical diagnosis of vaginal atrophy who will not need systemic estrogen therapy for the treatment of vasomotor symptoms or prophylaxis of osteoporosis
- •Any parity.
排除标准
- •Women with any history of carcinoma of the breast or endometrium,
- •abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disorders associated with previous estrogen use,
- •or current urinary.
- •In addition, women who underwent hormone replacement therapy, treated with systemic or vaginal estrogen within 6 months prior to the study,
- •or had any contraindication for estrogen therapy will be excluded from the study.
研究组 & 干预措施
the first group estrogen group
they will receive estrogen conjugate vaginal cream one tube every night for 14 nights; then, one tube 2 nights in 1 week (two tubes every week) for 10 weeks.
干预措施: Conjugated Estrogens vaginal cream 0,625mg (Drug)
the second group PRP group
they will receive a Platelet-rich plasma injection every 3 weeks for 4 times. PRP will be administered to the anterior vaginal wall using 27-G needles o and it is mainly injected into the anterior wall of the vagina to increase the tactile sensitivity of the injection site.
干预措施: platelet rich plasma (Combination Product)
结局指标
主要结局
improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS).
时间窗: 12 week
Vulvovaginal atrophy (VVA) will be assessed at weeks 0, 4, 8 and 12. Participants will report intensity of VVA symptoms using a 10-cm VAS. The scale's left extremity indicates the complete absence of symptoms (0) and the right extremity indicates the worst possible symptom (10). Participants rated VVA symptoms (dyspareunia, dryness, or burning) from 0 to 10.
Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI)
时间窗: 12 week
The FSFI will be assessed at weeks 0,4 ,8 and 12 BY FSFI questionnaire addresses six different domains (desire, arousal, lubrication, orgasm, satisfaction, and pain/ discomfort) ranging from 0 (no sexual activity in the past 4 wk) or 1 (very dissatisfied) to 5 (very satisfied). Full scale scores ranging from 2.0 (severe dysfunction) to 36.0 (absence of dysfunction) will be used to evaluate sexual function throughout the study, with increased FSFI scores correlating to an improvement of symptoms. An optimal cut score of 26, reported by Wiegel etal, is currently used to differentiate between women with and without sexual dysfunction.
improvement in Vaginal Health Index (VHI).
时间窗: 12 weeks
Vaginal Health Index (VHI) will be assessed at weeks 0, 4, 8 and 12. VHI analyzes the following five components on a scale of 1 to 5: elasticity, fluid volume, pH, epithelial integrity, and moisture.A minimal total score of 5 points indicates severe VVA, and a maximal total score of 25 points indicates no clinical signs of VVA
次要结局
- Assessment of tolerability and safety of Platelet rich plasma (PRP).(12 weeks)
- Assessment of tolerability and safety of estrogen vaginal cream(12 weeks)
研究者
rehab abdelhamid aboshama
lecturer of obstetrics and gynecology
Fayoum University