Introduction and Hypothesis <p>Genitourinary syndrome of menopause is a chronic and high prevalent condition with a substantial negative impact in women's&#xa0;quality of life and&#xa0;vaginal health. The prevalence of GSMis even higher among breast cancer survivors receiving endocrine adjuvant therapy.&#xa0;This study aimed to evaluate the efficacy and safety of CO<sub>2</sub> laser (CO<sub>2</sub>L), radiofrequency (RF), and promestriene in treating genitourinary syndrome of menopause (GSM) in this population.</p> Methods <p>A multi-arm randomized clinical trial enrolled postmenopausal women with breast cancer undergoing endocrine adjuvant therapy. Participants were randomized to receive CO<sub>2</sub>L, RF, or promestriene treatment. The study assessed before, 4, and 10&#xa0;months after treatment GSM symptoms, Vaginal Health Index (VHI), sexual function, and urinary symptoms using validated tools. Statistical analysis was performed to compare treatment outcomes and adverse events.</p> <p>The intensity and frequency of GSM signs and symptoms before and after the proposed therapies were evaluated, along with their impact on health-related quality of life, patient satisfaction, and the presence of adverse events related to the treatments, during the 10 months follow-up.</p> Results <p>Fifty-eight women completed the treatment and the 10-month follow-up (21 CO<sub>2</sub>L, 19 RF, 18 promestriene). The groups were similar regarding the intensity of vaginal health symptoms and demographic parameters. All treatment groups showed significant improvement in GSM symptoms, VHI, and sexual function. Urinary symptoms were reduced in the CO<sub>2</sub>L and RF groups, with sustained improvement at the 10-month follow-up. Adverse events were mild and well tolerated, with no serious complications reported.</p> Conclusions <p>CO<sub>2</sub>L, RF, and promestriene demonstrated efficacy in improving GSM symptoms, VHI, and sexual function in breast cancer survivors receiving adjuvant endocrine therapy. These treatments offer safe and effective alternatives for managing GSM in this population, with potential benefits for health-related quality of life and treatment adherence.</p>

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Laser, radiofrequency, and promestriene in the treatment of genitourinary syndrome of menopause in breast cancer survivors: randomized clinical trial

  • Chayane Dedonatto,
  • Ana Maria Homem de Mello Bianchi-Ferraro,
  • Rita de Cassia de Maio Dardes,
  • Marair Gracio Ferreira Sartori,
  • G C Cantarelli,
  • R B Vanzin,
  • M F R Fernandes,
  • A C Nazario,
  • Z I K Jarmy di – Bella,
  • Marisa Teresinha Patriarca

摘要

Introduction and Hypothesis

Genitourinary syndrome of menopause is a chronic and high prevalent condition with a substantial negative impact in women's quality of life and vaginal health. The prevalence of GSMis even higher among breast cancer survivors receiving endocrine adjuvant therapy. This study aimed to evaluate the efficacy and safety of CO2 laser (CO2L), radiofrequency (RF), and promestriene in treating genitourinary syndrome of menopause (GSM) in this population.

Methods

A multi-arm randomized clinical trial enrolled postmenopausal women with breast cancer undergoing endocrine adjuvant therapy. Participants were randomized to receive CO2L, RF, or promestriene treatment. The study assessed before, 4, and 10 months after treatment GSM symptoms, Vaginal Health Index (VHI), sexual function, and urinary symptoms using validated tools. Statistical analysis was performed to compare treatment outcomes and adverse events.

The intensity and frequency of GSM signs and symptoms before and after the proposed therapies were evaluated, along with their impact on health-related quality of life, patient satisfaction, and the presence of adverse events related to the treatments, during the 10 months follow-up.

Results

Fifty-eight women completed the treatment and the 10-month follow-up (21 CO2L, 19 RF, 18 promestriene). The groups were similar regarding the intensity of vaginal health symptoms and demographic parameters. All treatment groups showed significant improvement in GSM symptoms, VHI, and sexual function. Urinary symptoms were reduced in the CO2L and RF groups, with sustained improvement at the 10-month follow-up. Adverse events were mild and well tolerated, with no serious complications reported.

Conclusions

CO2L, RF, and promestriene demonstrated efficacy in improving GSM symptoms, VHI, and sexual function in breast cancer survivors receiving adjuvant endocrine therapy. These treatments offer safe and effective alternatives for managing GSM in this population, with potential benefits for health-related quality of life and treatment adherence.