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Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Primary Purpose

Senile Vaginitis

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Senile Vaginitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ain shams UniversityRecruiting
  • Ain shams university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm 29

Arm 30

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1 PRP

2 PRP

3 PRP

4 PRP

5 PRP

6 PRP

7 PRP

8 PRP

9 PRP

10 PRP

11 PRP

12 PRP

13 PRP

14 PRP

15 PRP

16 PRP

17 PRP

18 PRP

19 PRP

20 PRP

21 PRP

22 PRP

23 PRP

24 PRP

25 PRP

26 PRP

27PRP

28 PRP

29 PRP

30 PRp

Arm 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of vaginal mucosa using vaginal health index score
Elasticity,fluid volume,integrity,pH,moisture

Secondary Outcome Measures

Female Sexual Distress (FSD) scale
How often did you feel distreesed about your sexual life ?

Full Information

First Posted
March 19, 2019
Last Updated
March 29, 2019
Sponsor
Ain Shams University
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
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1. Study Identification

Unique Protocol Identification Number
NCT03898401
Brief Title
Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
Official Title
Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Netherlands: Ministry of Health, Welfare and Sports

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: 5 cc syringes. 27 gauge needles. Centrifuge with proprietary collection system. Calcium chloride 10% (for activation of PRP). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Senile Vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 PRP
Arm Type
Experimental
Arm 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.
Arm Title
2 PRP
Arm Type
Experimental
Arm 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.
Arm Title
3 PRP
Arm Type
Experimental
Arm 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.
Arm Title
4 PRP
Arm Type
Experimental
Arm 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.
Arm Title
5 PRP
Arm Type
Experimental
Arm 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.
Arm Title
6 PRP
Arm Type
Experimental
Arm 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.
Arm Title
7 PRP
Arm Type
Experimental
Arm 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.
Arm Title
8 PRP
Arm Type
Experimental
Arm 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.
Arm Title
9 PRP
Arm Type
Experimental
Arm 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.
Arm Title
10 PRP
Arm Type
Experimental
Arm 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.
Arm Title
11 PRP
Arm Type
Experimental
Arm 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.
Arm Title
12 PRP
Arm Type
Experimental
Arm 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.
Arm Title
13 PRP
Arm Type
Experimental
Arm 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.
Arm Title
14 PRP
Arm Type
Experimental
Arm 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.
Arm Title
15 PRP
Arm Type
Experimental
Arm 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.
Arm Title
16 PRP
Arm Type
Experimental
Arm 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.
Arm Title
17 PRP
Arm Type
Experimental
Arm 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.
Arm Title
18 PRP
Arm Type
Experimental
Arm 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.
Arm Title
19 PRP
Arm Type
Experimental
Arm 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.
Arm Title
20 PRP
Arm Type
Experimental
Arm 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.
Arm Title
21 PRP
Arm Type
Experimental
Arm 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.
Arm Title
22 PRP
Arm Type
Experimental
Arm 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.
Arm Title
23 PRP
Arm Type
Experimental
Arm 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.
Arm Title
24 PRP
Arm Type
Experimental
Arm 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.
Arm Title
25 PRP
Arm Type
Experimental
Arm 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.
Arm Title
26 PRP
Arm Type
Experimental
Arm 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.
Arm Title
27PRP
Arm Type
Experimental
Arm 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.
Arm Title
28 PRP
Arm Type
Experimental
Arm 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.
Arm Title
29 PRP
Arm Type
Experimental
Arm 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.
Arm Title
30 PRp
Arm Type
Experimental
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Platelet rich plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of vaginal mucosa using vaginal health index score
Description
Elasticity,fluid volume,integrity,pH,moisture
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Female Sexual Distress (FSD) scale
Description
How often did you feel distreesed about your sexual life ?
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Medhat, Professor
Phone
01224448449
Email
rashamedhat30@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasha Medhat, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shams University
City
Cairo
State/Province
Elabbasia
ZIP/Postal Code
13211
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasha Abdulhady
Phone
01224448449
Email
rashamedhat30@gmail.com
First Name & Middle Initial & Last Name & Degree
Rasha Abdulhady
Facility Name
Ain shams university hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasha M Abdul-hady, Lecturer
Phone
+20122 444 8449
Email
Rashamedhat30@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

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