Senile Vaginitis Clinical Trial
Official title:
Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
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.
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:
1. 5 cc syringes.
2. 27 gauge needles.
3. Centrifuge with proprietary collection system.
4. Calcium chloride 10% (for activation of PRP).
5. 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.
Study Interventions:
After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to
activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth
factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin
matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than
10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal
wall and perform clinical evaluations at 0, 1, 3, and 6 months.
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