Management of Cancer Therapy Related Vulvovaginal Atrophy

Not Applicable

Completed

• Conditions: Genitourinary Syndrome of Menopause
• Interventions: Device: Platelet rich plasma; Device: topical HA gel; Device: non cross-linked hyaluronic acid

• Registration Number: NCT05782920
• Lead Sponsor: Alexandria University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-30
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Study First Submitted: 2023-02-19
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP-HA treated Group B	Platelet rich plasma	15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart.
PRP- treated Group A	Platelet rich plasma	15 female patients will receive 2 vaginal PRP injections one month apart.
PRP-HA treated Group B	non cross-linked hyaluronic acid	15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart.
Control Group C	topical HA gel	15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group

Primary Outcome Measures

Name	Time	Method
Vulvovaginal atrophy vaginal dryness severity scores	3 months follow up	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy dyspareunia severity scores	3 months follow up	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vaginal health index total score	3 months follow up	scores range from 5-25 with lower scores signifying greater atrophy

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt