Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Evaluation of vaginal mucosa using vaginal health index score
研究概览
简要总结
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
详细描述
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
The patients will be seen in Ain shams university gynecological clinic and will not be paid either to receive the procedure or to complete the survey. All patients were fully informed of the innovative therapeutic and experimental nature of the localized PRP injection and consented to the procedure.
The materials and equipment included the following:
- 5 cc syringes.
- 27 gauge needles.
- Centrifuge with proprietary collection system.
- Calcium chloride 10% (for activation of PRP).
- and a topical anesthetic cream compounded with a base that prevents irritation and promotes absorption through the vaginal mucosa. Active ingredients will be as follows: bupivicaine, lidocaine, and tetracaine with percent concentrations of 20/8/8 respectively.
First, a topical anesthetic cream will be applied to the posterior vaginal wall. Delaying the PRP injection for 20 minutes after anesthetic application achieved complete or near complete analgesia for the procedure. Peripheral blood will be drawn from the arm and centrifuged to yield 5 cc of PRP. The Regen® system concentrates 5ml of PRP from 10 ml of whole blood using a gel separator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal for at least 3 years.
- •Vaginal health index <
- •Any parity.
排除标准
- •Women with vaginal infection.
- •Women taking estrogen therapy for senile vaginitis.
- •Any patient with medical disorder especially diabetes mellitus.
- •Previous vaginal surgery as fistula repair or classical repair.
- •Vaginal prolapse
- •Any patient taking chemo or radiotherapy.
研究组 & 干预措施
1 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
2 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
3 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
4 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
5 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
6 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
7 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
8 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
9 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
10 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
11 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
12 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
13 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
14 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
15 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
16 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
17 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
18 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
19 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
20 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
21 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
22 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
23 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
24 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
25 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
26 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
27PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
28 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
29 PRP
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
30 PRp
Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.
干预措施: Platelet rich plasma (Combination Product)
结局指标
主要结局
Evaluation of vaginal mucosa using vaginal health index score
时间窗: 6 months
Elasticity,fluid volume,integrity,pH,moisture
次要结局
- Female Sexual Distress (FSD) scale(6 months)
研究者
rasha medhat abdul-hady
Clinical professor
Ain Shams University