NCT07420647

Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Cancer Treatment

The Pilot Project on Individualized Treatment of Genitourinary Syndrome of Menopause in Women After Oncological Treatment: A Prospective Interventional Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. GSM is a common condition in postmenopausal women and may include symptoms such as vaginal dryness, irritation, pain during intercourse, and urinary discomfort. These symptoms can significantly affect quality of life and sexual function, particularly in women after cancer treatment. The purpose of this study is to assess whether a personalized, non-hormonal treatment approach can effectively reduce GSM symptoms and improve overall quality of life and sexual function in this patient population. Participants will be assigned to an intervention group or a control group and will be followed prospectively over time. The study will include women in menopause who have completed oncological treatment and experience symptoms of GSM. Clinical assessments, patient-reported outcomes, and quality-of-life questionnaires will be used to evaluate treatment effectiveness and safety. The results of this pilot study may help inform future clinical practice and support the development of individualized, non-hormonal treatment strategies for women with GSM after cancer treatment.

Conditions

• Genitourinary Syndrome of Menopause (GSM)
• Vaginal Dryness
• Menopause
• Female Cancer Survivors

Interventions

Type	Name	Description
DEVICE	Non-ablative vaginal Er:YAG laser therapy	Non-ablative vaginal erbium-doped yttrium aluminum garnet (Er:YAG) laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting.
DEVICE	Non-ablative vaginal Er:YAG laser therapy	Non-ablative vaginal Er:YAG laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting.
OTHER	Standard care	Standard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention.

Timeline

• Start date: 2024-10-15
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Slovenia