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The goal of this clinical trial is to:
Patients will be divided randomly into 3 groups:
Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid.
Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.
Full description
The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17)
The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between.
3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months.
Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment.
Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale.
Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No).
For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy.
Assessment of sexual satisfaction of both male and female partners:
Sexual satisfaction was measured using the Arabic version of the Index of Sexual Satisfaction (ISS) and female sexual function index (FSFI) questionnaire.
Enrollment
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Inclusion criteria
Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia)
Exclusion criteria
Active or recent history of vulvovaginal inflammation or infection
Primary purpose
Allocation
Interventional model
Masking
45 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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