LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Estradiol

Criteria

Inclusion Criteria:

1. Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy

2. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy:

• Burning

• Discomfort

• Dryness

• Cracks

• Pruritus

• Lack of vaginal lubrication

• Penetration dyspareunia that began at the menopausal or postmenopausal transition

• Decreased vaginal epithelium turgor and trophism

• Deletion of mucous and skin folds.

3. Absence of vaginal surgical procedure in the last year

4. Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0

Exclusion Criteria:

1. Active genital infection

2. Active infection of HPV (human papillomavirus) or Herpes

3. users of medications with estrogenic effect (digoxin and other chemicals)

4. Postmenopausal genital bleeding

5. uncontrolled diabetes

6. use of multivitamins with zinc

7. use of copper or hormonal IUDs (intrauterine device) at the time of inclusion

8. presence of genitourinary or rectovaginal fistulas