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临床试验/NCT07452796
NCT07452796尚未招募不适用

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

Izmir Democracy University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年4月15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
发起方
入组人数
130
试验地点
1
主要终点
Urgency, Severity and Impact Questionnaire (USIQ)

研究概览

简要总结

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.

详细描述

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.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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/exclusion criteria.

干预措施: Observational Cohort (Other)

结局指标

主要结局

Urgency, Severity and Impact Questionnaire (USIQ)

时间窗: At Baseline

The USIQ, developed by Lowenstein et al. in 2009, is a patient-reported instrument assessing the severity of urgency symptoms and their impact on quality of life. It consists of two subscales: USIQ-S (Symptom Severity) with 5 items measuring urgency complaints, and USIQ-QOL (Quality of Life) with 8 items assessing the effect on daily life, totaling 13 items. Responses are scored 0-4, with an additional "Don't know"/"Not applicable" option excluded from scoring. USIQ-S and USIQ-QOL scores are calculated by averaging item scores and multiplying by 25, yielding a 0-100 scale. Higher scores indicate more severe urgency symptoms and greater impact on quality of life. Cronbach's alpha values are 0.85 for USIQ-S and 0.90 for USIQ-QOL.

Incontinence Impact Questionnaire-Short Form (IIQ-7)

时间窗: At baseline

The IIQ-7, developed as a short form in 1995, evaluates the impact of urinary incontinence on women's daily quality of life. It includes 7 items addressing household chores, physical activity, social activity, travel, and emotional well-being. Each item is scored 0-3: 'Not at all' (0), 'Slightly' (1), 'Moderately' (2), and 'Greatly' (3). Total scores are summed and standardized to a 0-100 scale, with higher scores indicating greater negative impact on quality of life. Internal consistency (Cronbach's alpha) ranges from 0.87 to 0.90. The Turkish version was validated by Cam in 2007.

Urogenital Distress Inventory-Short Form (UDI-6)

时间窗: At baseline

The UDI-6 Short Form, developed in 1995, assesses urogenital symptoms including stress urinary incontinence, urgency incontinence, frequency, small amounts of urine leakage, voiding phase complaints, and pelvic/perineal discomfort. It does not directly assess the impact on quality of life. Each item is scored 0-3 to indicate the distress caused: 'Not at all' (0), 'A little bit' (1), 'Moderately' (2), and 'Greatly' (3). Item scores are summed and standardized to a 0-100 scale, with higher scores reflecting greater symptom distress. Internal consistency (Cronbach's alpha) for subscales ranges from 0.48 to 0.77. The Turkish version was validated by Cam in 2007.

International Consultation on Incontinence Modular Questionnaire-Overactive Bladder Quality of Life Questionnaire (ICIQ-OABqol / OAB-q)

时间窗: At baseline

The OAB-q, developed in 2002, measures symptom bother and disease-specific quality of life in patients with overactive bladder, applicable to both incontinent and continent patients. The questionnaire has 33 items: 8 assess symptom bother and 25 assess quality of life across coping (8 items), concern (7 items), social interaction (5 items), and sleep (5 items). All items use a 6-point Likert scale. Symptom bother items are scored from 1 ('Not at all') to 6 ('A very great deal'), while quality of life items are scored from 1 ('None of the time') to 6 ('All of the time'). Raw scores are standardized to a 0-100 scale, with higher symptom bother scores indicating increased symptom severity, and higher quality of life scores indicating better quality of life. Internal consistency (Cronbach's alpha) ranges from 0.86 to 0.94. The Turkish version was validated in 2008.

次要结局

未报告次要终点

研究者

发起方
Izmir Democracy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betül Taşpınar

Prof.Dr.

Izmir Democracy University

研究点 (1)

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