Management of Cancer Therapy Related Vulvovaginal Atrophy

Study Overview
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Brief Summary
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The goal of this clinical trial is to: evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy. To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners. 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.

Detailed Description
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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. 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.

Official Title
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Comparison Between Platelet-rich Plasma (PRP) and Hyaluronic Acid (HA) in the Treatment of Cancer-therapy Related Vulvovaginal Atrophy and Its Impact on Sexual Satisfaction

Conditions
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Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Device: Platelet rich plasma
* Device: non cross-linked hyaluronic acid
* Device: topical HA gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia) Patients with vaginal health index < 15. All patients have already finished cancer therapy or are on anti-estrogen treatment. Married sexually active Patients who are not receiving any VVA treatment for at least 30 days before starting therapy. Exclusion Criteria: Active or recent history of vulvovaginal inflammation or infection History of vulvar or vaginal cancer. Suspicious lesion in the vulvovaginal area on the gynecological examination

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP- treated Group A<br>15 female patients will receive 2 vaginal PRP injections one month apart. | Device: Platelet rich plasma<br>* PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.<br>|
| Active Comparator: PRP-HA treated Group B<br>15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart. | Device: Platelet rich plasma<br>* PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.<br>Device: non cross-linked hyaluronic acid<br>* HA filling is a known modality for rejuvenation<br>|
| Active Comparator: Control Group C<br>15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group | Device: topical HA gel<br>* the standard treatment of vaginal atrophy and dryness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |