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Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03898401
Enrollment
30
Registered
2019-04-02
Start date
2019-03-18
Completion date
2019-10-30
Last updated
2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Senile Vaginitis

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.

Interventions

COMBINATION_PRODUCTPlatelet rich plasma

After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.

Sponsors

Netherlands: Ministry of Health, Welfare and Sports
CollaboratorOTHER_GOV
Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of vaginal mucosa using vaginal health index score6 monthsElasticity,fluid volume,integrity,pH,moisture

Secondary

MeasureTime frameDescription
Female Sexual Distress (FSD) scale6 monthsHow often did you feel distreesed about your sexual life ?

Countries

Egypt

Contacts

Primary ContactRasha Medhat, Professor
rashamedhat30@gmail.com01224448449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026