Clinical and histomorphometric evaluation of the vagina following treatment with CO2 laser, radiofrequency, and promestriene for genitourinary syndrome of menopause in breast cancer survivors on adjuvant therapy

Maturitas. 2025 Jan:191:108155. doi: 10.1016/j.maturitas.2024.108155. Epub 2024 Nov 14.

Abstract

Purpose: To perform clinical and histomorphometric evaluations of the vagina before and after treatment for genitourinary syndrome of menopause with CO2 laser, fractional radiofrequency, and promestriene in breast cancer survivors using adjuvant endocrine therapy.

Methods: The study included women experiencing moderate to severe genitourinary syndrome of menopause. Following pre- and post-treatment protocols, participants graded their symptoms on a visual analog scale and underwent a gynecological examination to evaluate the Vaginal Health Index and obtain a vaginal biopsy. Subsequently, they were randomized to laser, radiofrequency, and promestriene groups. The energy groups underwent three consecutive monthly outpatient vulvovaginal treatments, while the control group received promestriene treatment for four months, followed by a post-treatment evaluation.

Results: Sixty-two women completed the study protocol (21 laser, 20 radiofrequency, and 21 promestriene). While histological differences (vaginal thickness [p = 0.002] and number of stromal papillae [p = 0.004]) were observed between the pretreatment samples of tamoxifen and anastrozole users, the symptoms did not differ between them. A decrease in symptom intensity (p < 0.05) and an improvement in the Vaginal Health Index (p < 0.001) were observed post-treatment, regardless of the type of adjuvant endocrine therapy used. Most pretreatment vaginal samples did not indicate histological atrophy, and no significant histological differences were observed after treatment. No clinical or histological damage was observed.

Conclusion: CO2 laser and radiofrequency therapies could be considered alternative treatments for genitourinary syndrome of menopause in breast cancer survivors receiving adjuvant therapy. These treatments promoted significant improvements comparable to those delivered by promestriene, without histological or clinical tissue damage.

Trial registration number: NCT04081805.

Keywords: Breast cancer; CO(2) laser; Fractional radiofrequency; Genitourinary syndrome of menopause; Promestriene; Vaginal biopsy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anastrozole / therapeutic use
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / pathology
  • Breast Neoplasms* / therapy
  • Cancer Survivors*
  • Chemotherapy, Adjuvant / methods
  • Estradiol / analogs & derivatives
  • Female
  • Female Urogenital Diseases* / etiology
  • Female Urogenital Diseases* / therapy
  • Humans
  • Lasers, Gas* / therapeutic use
  • Menopause*
  • Middle Aged
  • Radiofrequency Therapy / methods
  • Syndrome
  • Tamoxifen* / therapeutic use
  • Vagina* / pathology
  • Vagina* / radiation effects

Substances

  • Tamoxifen
  • promestriene
  • Anastrozole
  • Antineoplastic Agents, Hormonal
  • Estradiol

Associated data

  • ClinicalTrials.gov/NCT04081805