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

NCT07420647 | Active Not Recruiting

• 3 other identifiers: OI-GSM-2024-01ERID-KSOPR-0060/2024ERIDEK-0073/2024
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Genitourinary Syndrome of Menopause; GSM; Vaginal Dryness; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Individualized GSM Treatment Arm

EXPERIMENTAL

Device: Non-ablative vaginal Er:YAG laser therapy

Standard Care Control Arm

ACTIVE COMPARATOR

Other: Standard care

Interventions

Non-ablative vaginal Er:YAG laser therapy DEVICE

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.

Individualized GSM Treatment Arm

Standard care OTHER

Standard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention.

Standard Care Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either an individualized intervention group or a control group receiving standard care, and outcomes are compared between groups.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: October 15, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)