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临床试验/NCT07690137
NCT07690137尚未招募不适用

Comparison of Lower Urinary Tract Symptoms, Bowel Function, and Sexual Health Across Menopausal Stages in Women

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
试验地点
1
主要终点
Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score

研究概览

简要总结

The menopausal transition is associated with substantial hormonal alterations that may adversely affect lower urinary tract function, bowel function, and sexual health. Although these symptoms are common, few studies have comprehensively evaluated all three pelvic floor compartments across different menopausal stages.

The aim of this study is to compare lower urinary tract symptoms, bowel symptoms, and female sexual function among women in the perimenopausal, early postmenopausal, and late postmenopausal stages. In addition, the relationship between menopausal stage and symptom severity will be investigated.

详细描述

Menopause is characterized by estrogen deficiency, resulting in structural and functional alterations in pelvic floor tissues. Lower urinary tract symptoms, bowel dysfunction, and female sexual dysfunction are increasingly recognized as important health concerns during the menopausal transition.

Despite growing evidence regarding individual pelvic floor disorders, few studies have simultaneously evaluated urinary, colorectal, and sexual symptoms across different menopausal stages.

This study will classify women according to STRAW+10 criteria into:

Perimenopause Early postmenopause Late postmenopause

Participants will undergo a single assessment session. Demographic information together with validated questionnaires will be collected. No intervention or treatment will be provided.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 40-65 years
  • Intact uterus and at least one ovary
  • Perimenopause or postmenopause according to STRAW+10 criteria
  • Able to read and understand Turkish

排除标准

  • Hormone replacement therapy within the previous 6 months
  • Oral contraceptive use
  • Antipsychotic medication use
  • Previous pelvic surgery
  • Neurological or systemic diseases affecting bladder or bowel function
  • Active urinary tract or vaginal infection
  • Pelvic radiotherapy or chemotherapy history
  • Active gynecological or urological malignancy
  • Alcohol or substance abuse during the previous year

研究组 & 干预措施

Perimenopause

Perimenopausal women according to STRAW+10 criteria

干预措施: Constipation Severity Assessment (Other)

Late postmenopause

Late postmenopausal women according to STRAW+10 criteria

干预措施: Constipation Severity Assessment (Other)

Perimenopause

Perimenopausal women according to STRAW+10 criteria

干预措施: Assessment for Bowel Symptoms (Other)

Perimenopause

Perimenopausal women according to STRAW+10 criteria

干预措施: Sexual Function Assessment (Other)

Early postmenopause

Early postmenopausal women according to STRAW+10 criteria

干预措施: Assessment for Lower Urinary Tract Symptoms (Other)

Perimenopause

Perimenopausal women according to STRAW+10 criteria

干预措施: Assessment for Lower Urinary Tract Symptoms (Other)

Early postmenopause

Early postmenopausal women according to STRAW+10 criteria

干预措施: Assessment for Bowel Symptoms (Other)

Early postmenopause

Early postmenopausal women according to STRAW+10 criteria

干预措施: Constipation Severity Assessment (Other)

Early postmenopause

Early postmenopausal women according to STRAW+10 criteria

干预措施: Sexual Function Assessment (Other)

Late postmenopause

Late postmenopausal women according to STRAW+10 criteria

干预措施: Assessment for Lower Urinary Tract Symptoms (Other)

Late postmenopause

Late postmenopausal women according to STRAW+10 criteria

干预措施: Assessment for Bowel Symptoms (Other)

Late postmenopause

Late postmenopausal women according to STRAW+10 criteria

干预措施: Sexual Function Assessment (Other)

结局指标

主要结局

Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score

时间窗: Baseline (single assessment)

Lower urinary tract symptoms will be assessed using the validated Bristol Female Lower Urinary Tract Symptoms questionnaire. Higher scores indicate greater symptom severity and poorer urinary health-related quality of life

次要结局

  • Colorectal Anal Distress Inventory-8 (CRADI-8)(Baseline (single assessment))
  • Cleveland Clinic Constipation Score(Baseline (single assessment))
  • Female Sexual Function Index(Baseline (single assessment))
  • Bristol Stool Form Scale(Baseline (single assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betül Çınar

Associated professor

Bezmialem Vakif University

研究点 (1)

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