Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Ain Shams University

Status and phase: Unknown; Phase 1

Conditions: Senile Vaginitis

Treatments: Combination Product: Platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03898401

2455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 30 patient groups

1 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

2 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

3 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

4 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

5 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

6 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

7 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

8 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

9 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

10 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

11 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

12 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

13 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

14 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

15 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

16 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

17 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

18 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

19 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

20 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

21 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

22 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

23 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

24 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

25 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

26 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

27PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

28 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

29 PRP

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma

30 PRp

Experimental group

Description:

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.

Treatment:

Combination Product: Platelet rich plasma