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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Menopause; Vaginal Dryness; Genitourinary Syndrome of Menopause (GSM); Female Cancer Survivors
• Intervention / Treatment: Device: Non-ablative vaginal Er:YAG laser therapy; Device: Non-ablative vaginal Er:YAG laser therapy; Other: Standard care

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Female sex.

Postmenopausal women.

History of oncological treatment (e.g., gynecological or other malignancies).

Presence of genitourinary syndrome of menopause (GSM), including symptoms such as vaginal dryness, dyspareunia, burning, irritation, or urinary symptoms.

Completion of primary oncological treatment prior to enrollment.

Age ≥ 18 years.

Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

Current pregnancy or premenopausal status.

Active malignant disease requiring ongoing oncological treatment.

Acute genital or urinary tract infection at the time of enrollment.

Prior participation in another interventional clinical study that could influence study outcomes.

Known hypersensitivity or contraindication to study-related interventions.

Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care Control Arm	Other: Standard care; Standard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention.
Experimental: Individualized GSM Treatment Arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms	The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.	Baseline
Change in Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms	The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.	Throughout study completion: 3 times, every 4 weeks

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Genitourinary Syndrome of Menopause; Vaginal Dryness; GSM
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: OI-GSM-2024-01; ERID-KSOPR-0060/2024 (Other Identifier: Institute of Oncology Ljubljana - Commission for Scientific Review of Research Protocols (KSOPR)); ERIDEK-0073/2024 (Other Identifier: Institute of Oncology Ljubljana - Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No