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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.
9. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP- treated Group A | Active Comparator | 15 female patients will receive 2 vaginal PRP injections one month apart. |
|
| PRP-HA treated Group B | Active Comparator | 15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart. |
|
| Control Group C | Active Comparator | 15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma | Device | PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vulvovaginal atrophy vaginal dryness severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | before treatment |
| Vulvovaginal atrophy vaginal dryness severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | after 1 month |
| Vulvovaginal atrophy vaginal dryness severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | after 2 months |
| Vulvovaginal atrophy vaginal dryness severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | 3 months follow up |
| Vulvovaginal atrophy dyspareunia severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | before treatment |
| Vulvovaginal atrophy dyspareunia severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | after 1 month |
| Vulvovaginal atrophy dyspareunia severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms |
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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
females only will be included
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| Name | Affiliation | Role |
|---|---|---|
| Salma Omar, MD | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | 25211 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29738415 | Background | Hersant B, SidAhmed-Mezi M, Belkacemi Y, Darmon F, Bastuji-Garin S, Werkoff G, Bosc R, Niddam J, Hermeziu O, La Padula S, Meningaud JP. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Menopause. 2018 Oct;25(10):1124-1130. doi: 10.1097/GME.0000000000001122. | |
| 37417970 |
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| non cross-linked hyaluronic acid | Device | HA filling is a known modality for rejuvenation |
|
| topical HA gel | Device | the standard treatment of vaginal atrophy and dryness |
|
| after 2 months |
| Vulvovaginal atrophy dyspareunia severity scores | scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms | 3 months follow up |
| Vaginal health index total score | scores range from 5-25 with lower scores signifying greater atrophy | before treatment |
| Vaginal health index total score | scores range from 5-25 with lower scores signifying greater atrophy | after 1 month |
| Vaginal health index total score | scores range from 5-25 with lower scores signifying greater atrophy | after 2 months |
| Vaginal health index total score | scores range from 5-25 with lower scores signifying greater atrophy | 3 months follow up |
| Derived |
| Omar SS, Elmulla KF, AboKhadr NA, Badawy AA, Ramadan EN, Hassouna AM, Heikal LA, Arafat WO. Comparable Efficacy of Submucosal Platelet-Rich Plasma and Combined Platelet-Rich Plasma Noncrosslinked Hyaluronic Acid Injections in Vulvovaginal Atrophy: A Cancer Survivorship Issue. J Womens Health (Larchmt). 2023 Sep;32(9):1006-1020. doi: 10.1089/jwh.2023.0144. Epub 2023 Jul 7. |