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Набор скоро начнётся NCT07690137

Pelvic Floor Symptoms Across Menopausel Stages

— Наблюдательное Menopause Perimenopausal Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Assessment for Lower Urinary Tract Symptoms, Assessment for Bowel Symptoms, Constipation Severity Assessment, Sexual Function Assessment.
Кому может быть актуально
Состояния в реестре: Menopause, Perimenopausal Disorder. Базовые параметры: 40 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Assessment for Lower Urinary Tract Symptoms
    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.
  • Другое Assessment for Bowel Symptoms
    Bowel symptoms and colorectal-anal distress will be evaluated using the Colorectal Anal Distress Inventory-8. Higher scores indicate greater symptom severity and distress related to bowel dysfunction.
  • Другое Constipation Severity Assessment
    Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.
  • Другое Sexual Function Assessment
    Female sexual function will be assessed using the Female Sexual Function Index, a validated questionnaire evaluating desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.

Первичные конечные точки

  • Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score [Срок оценки: Baseline (single assessment)]
Вторичные конечные точки (4)
  • Colorectal Anal Distress Inventory-8 (CRADI-8) [Срок оценки: Baseline (single assessment)]
  • Cleveland Clinic Constipation Score [Срок оценки: Baseline (single assessment)]
  • Bristol Stool Form Scale [Срок оценки: Baseline (single assessment)]
  • Female Sexual Function Index [Срок оценки: Baseline (single assessment)]

Критерии участия

Критерии включения

  • Female
  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bezmialem Vakif University — Istanbul

Идентификаторы

NCT: NCT07690137 · bvubcinar05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗