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Набор скоро начнётся NCT07452796

Turkish USIQ: Validity & Reliability

— Наблюдательное Overactive Bladder

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: Observational Cohort.
Кому может быть актуально
Состояния в реестре: Overactive Bladder. Базовые параметры: 18 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

Validity and Reliability of the Turkish Version of the Urgency, Severity, and Impact Questionnaire (USIQ)

Обзор

The Urgency, Severity, and Impact Questionnaire (USIQ) assesses urinary urgency independently of incontinence, measuring both symptom severity and its impact on quality of life. While validated in English and Hebrew populations, a Turkish version has not yet been developed. This study aims to adapt USIQ for the Turkish population and evaluate its psychometric properties, providing a standardized, culturally relevant tool for clinical and research use.

Подробное описание

The International Continence Society (ICS) defines urinary urgency as "a sudden and compelling desire to urinate that is difficult to defer." According to this definition, urgency is an abnormal sensation that can be distinguished from the normal "urge to urinate" occurring during routine bladder filling. Urinary urgency is the core symptom of Overactive Bladder (OAB) syndrome and is often accompanied by daytime frequency and nocturia; urge incontinence may also occur. Epidemiological studies show that OAB symptoms are common in the adult population and increase in prevalence with age. Urinary urgency is reported by patients as one of the main symptoms negatively affecting quality of life. Consequently, the severity of urgency has a multidimensional impact on health-related quality of life.

Because of the subjective nature of urgency and the tendency of patients to confuse "normal urge" with "urinary urgency," its measurement is challenging. Since there is no gold-standard objective measure for urinary urgency and its severity, accurate assessment of this symptom is essential. Although many scales have been developed to assess OAB severity and its impact on quality of life, most address urgency together with incontinence or do not sufficiently assess severity. This represents a significant methodological gap leading to incomplete evaluation of symptoms.

To address this gap, the Urgency, Severity, and Impact Questionnaire (USIQ) was developed. USIQ evaluates urinary urgency independently of incontinence, adheres to ICS definitions, and measures both symptom severity (USIQ-S) and its impact on quality of life (USIQ-QOL) separately. Unlike other OAB questionnaires, USIQ allows assessment of urgency severity and its effects on quality of life regardless of continence status.

For a scale to be used in a different culture and language, it must be adapted and its psychometric properties tested. While USIQ has been validated in English and Hebrew populations, a Turkish version adapted for linguistic and cultural context and psychometrically evaluated has not yet been developed. Therefore, there is a clear need for a validated Turkish version of USIQ that measures urinary urgency severity and its impact on quality of life independently of incontinence.

Вмешательства

  • Другое Observational Cohort
    Women diagnosed with Overactive Bladder (OAB) attending the Gynecology and Oncology Clinic at Buca Seyfi Demirsoy Training and Research Hospital who meet inclusion and exclusion criteria. Participants will complete demographic and clinical questionnaires, including USIQ, IIQ-7, UDI-6, and OAB-q. Test-retest reliability will be assessed in a subgroup after 14 days.

Первичные конечные точки

  • Urgency, Severity and Impact Questionnaire (USIQ) [Срок оценки: At Baseline]
  • Incontinence Impact Questionnaire-Short Form (IIQ-7) [Срок оценки: At baseline]
  • Urogenital Distress Inventory-Short Form (UDI-6) [Срок оценки: At baseline]
  • International Consultation on Incontinence Modular Questionnaire-Overactive Bladder Quality of Life Questionnaire (ICIQ-OABqol / OAB-q) [Срок оценки: At baseline]

Критерии участия

Критерии включения

  • Women aged 18-65 years
  • Able to read and write in Turkish
  • Diagnosed with overactive bladder (OAB) presenting with urgency (either wet or dry type)
  • Willing to sign the informed consent form after being informed about the study

Критерии исключения

  • Urinary tract infection symptoms or an active infection diagnosis within the past month
  • Neurological conditions causing neurogenic bladder such as multiple sclerosis, Parkinson's disease, stroke, or spinal cord injury
  • Cognitive impairment preventing comprehension and completion of the questionnaires
  • Post-void residual urine volume (PVR) exceeding 150 mL
  • History of bladder stones, bladder tumors, or recent major urogenital surgery
  • Pregnancy or suspected pregnancy

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Betül TAŞPINAR — Konak

Идентификаторы

NCT: NCT07452796 · USIQ35

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗