- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898401
Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Rasha Medhat, Professor
- Phone Number: 01224448449
- Email: rashamedhat30@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Ain Shams University Hospital
-
Contact:
- Rasha M Abdul-hady, Lecturer
- Phone Number: +20122 444 8449
- Email: Rashamedhat30@gmail.com
-
-
Elabbasia
-
Cairo, Elabbasia, Egypt, 13211
- Recruiting
- Ain Shams University
-
Contact:
- Rasha Abdulhady
- Phone Number: 01224448449
- Email: rashamedhat30@gmail.com
-
Principal Investigator:
- Rasha Abdulhady
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 PRP
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. |
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.
|
Experimental: 2 PRP
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. |
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.
|
Experimental: 3 PRP
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. |
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.
|
Experimental: 4 PRP
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. |
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.
|
Experimental: 5 PRP
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. |
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.
|
Experimental: 6 PRP
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. |
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.
|
Experimental: 7 PRP
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. |
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.
|
Experimental: 8 PRP
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. |
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.
|
Experimental: 9 PRP
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. |
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.
|
Experimental: 10 PRP
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. |
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.
|
Experimental: 11 PRP
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. |
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.
|
Experimental: 12 PRP
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. |
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.
|
Experimental: 13 PRP
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. |
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.
|
Experimental: 14 PRP
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. |
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.
|
Experimental: 15 PRP
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. |
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.
|
Experimental: 16 PRP
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. |
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.
|
Experimental: 17 PRP
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. |
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.
|
Experimental: 18 PRP
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. |
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.
|
Experimental: 19 PRP
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. |
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.
|
Experimental: 20 PRP
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. |
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.
|
Experimental: 21 PRP
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. |
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.
|
Experimental: 22 PRP
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. |
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.
|
Experimental: 23 PRP
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. |
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.
|
Experimental: 24 PRP
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. |
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.
|
Experimental: 25 PRP
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. |
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.
|
Experimental: 26 PRP
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. |
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.
|
Experimental: 27PRP
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. |
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.
|
Experimental: 28 PRP
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. |
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.
|
Experimental: 29 PRP
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. |
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.
|
Experimental: 30 PRp
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of vaginal mucosa using vaginal health index score
Time Frame: 6 months
|
Elasticity,fluid volume,integrity,pH,moisture
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Female Sexual Distress (FSD) scale
Time Frame: 6 months
|
How often did you feel distreesed about your sexual life ?
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rasha Medhat, Professor, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Amneal Pharmaceuticals, LLCCompletedAtrophic Vaginitis Due to MenopauseUnited States
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Fayoum UniversityRecruitingAtrophic Vaginitis | Postmenopausal Atrophic VaginitisEgypt
Clinical Trials on Platelet rich plasma
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Stanford UniversityPartnership for Clean CompetitionCompletedRheumatic Diseases | TendinopathyUnited States
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VivaTech International, Inc.RecruitingOsteoarthritisUnited States
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Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingMenopause, Premature | Menopausal Syndrome | Premature Ovarian Failure | Ovarian Failure, Premature | Menopause Related ConditionsGreece
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Cardenal Herrera UniversityCompletedCarpal Tunnel SyndromeSpain
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Damascus UniversityCompletedBone ResorptionSyrian Arab Republic
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Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
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Peking University Third HospitalRecruiting
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Matthew GettmanCompleted
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Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
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EgymedicalpediaAl-Azhar UniversityCompletedUrinary Incontinence | Stress Urinary IncontinenceEgypt