Management of Cancer Therapy Related Vulvovaginal Atrophy

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782920
• Other study ID #: 0201349
• Status: Completed
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to:

1. 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.

2. 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.

Description:

1. 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)

2. 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.

1. 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).

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Genitourinary Syndrome of Menopause

Intervention

Device:
• Platelet rich plasma
PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.
• non cross-linked hyaluronic acid
HA filling is a known modality for rejuvenation
• topical HA gel
the standard treatment of vaginal atrophy and dryness

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	before treatment
Primary	Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	after 1 month
Primary	Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	after 2 months
Primary	Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	3 months follow up