Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Last updated: March 29, 2019
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

1

Condition

Vaginitis

Vaginal Atrophy

Treatment

N/A

Clinical Study ID

NCT03898401
2455
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal for at least 3 years.

  • Vaginal health index <15.

  • Any parity.

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 30
Study Start date:
March 18, 2019
Estimated Completion Date:
October 30, 2019

Study Description

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.

Connect with a study center

  • Ain shams University

    Cairo, Elabbasia 13211
    Egypt

    Active - Recruiting

  • Ain shams university hospital

    Cairo,
    Egypt

    Active - Recruiting

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