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ACTIVE NOT RECRUITING
NCT07420647
NA

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

Sponsor: Institute of Oncology Ljubljana

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2024-10-15

Completion Date

2027-10-01

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

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.

Locations (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia