The Pilot Project on Individualized Treatment of Genitourinary Syndrome of Menopause in Women After Oncological Treatment: A Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Individualized GSM Treatment Arm
干预措施: Non-ablative vaginal Er:YAG laser therapy (Device)
Standard Care Control Arm
干预措施: Standard care (Other)
结局指标
主要结局
Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
时间窗: Baseline
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.
Change in Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
时间窗: Throughout study completion: 3 times, every 4 weeks
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.
次要结局
未报告次要终点