Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Phase 1

• Conditions: Senile Vaginitis
• Interventions: Combination Product: Platelet rich plasma

• Registration Number: NCT03898401
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-18
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Postmenopausal for at least 3 years.
• Vaginal health index <15.
• Any parity.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10 PRP	Platelet rich plasma	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.
3 PRP	Platelet rich plasma	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.
6 PRP	Platelet rich plasma	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.
5 PRP	Platelet rich plasma	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.
13 PRP	Platelet rich plasma	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.
1 PRP	Platelet rich plasma	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.
2 PRP	Platelet rich plasma	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.
15 PRP	Platelet rich plasma	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.
17 PRP	Platelet rich plasma	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.
18 PRP	Platelet rich plasma	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.
4 PRP	Platelet rich plasma	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.
8 PRP	Platelet rich plasma	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.
11 PRP	Platelet rich plasma	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.
14 PRP	Platelet rich plasma	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.
7 PRP	Platelet rich plasma	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.
9 PRP	Platelet rich plasma	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.
12 PRP	Platelet rich plasma	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.
16 PRP	Platelet rich plasma	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.
19 PRP	Platelet rich plasma	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.
27PRP	Platelet rich plasma	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.
29 PRP	Platelet rich plasma	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.
20 PRP	Platelet rich plasma	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.
21 PRP	Platelet rich plasma	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.
22 PRP	Platelet rich plasma	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.
23 PRP	Platelet rich plasma	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.
30 PRp	Platelet rich plasma	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.
24 PRP	Platelet rich plasma	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.
28 PRP	Platelet rich plasma	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.
25 PRP	Platelet rich plasma	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.
26 PRP	Platelet rich plasma	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of vaginal mucosa using vaginal health index score	6 months	Elasticity,fluid volume,integrity,pH,moisture

Secondary Outcome Measures

Name	Time	Method
Female Sexual Distress (FSD) scale	6 months	How often did you feel distreesed about your sexual life ?

Trial Locations

Locations (2)

Ain shams University; 🇪🇬 Cairo, Elabbasia, Egypt

Ain shams university hospital; 🇪🇬 Cairo, Egypt