Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Senile Vaginitis Clinical Trial

Official title:

Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03898401
• Other study ID #: 2455
• Status: Recruiting
• Phase: Phase 1
• Start date: March 18, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2019
• Source: Ain Shams University
• Contact: Rasha Medhat, Professor
• Phone: 01224448449
• Email: rashamedhat30[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal for at least 3 years.

• Vaginal health index <15.

• Any parity.

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.

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Senile Vaginitis
• Vaginitis

Intervention

Combination Product:
• Platelet rich plasma
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.

Locations

Country	Name	City	State
Egypt	Ain shams University	Cairo	Elabbasia
Egypt	Ain shams university hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of vaginal mucosa using vaginal health index score	Elasticity,fluid volume,integrity,pH,moisture	6 months
Secondary	Female Sexual Distress (FSD) scale	How often did you feel distreesed about your sexual life ?	6 months