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NCT Number: NCT07452796

Turkish USIQ: Validity & Reliability

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Observational Cohort

Other

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.

Primary outcomes

  1. Urgency, Severity and Impact Questionnaire (USIQ)

    Time frame: 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.

  2. Incontinence Impact Questionnaire-Short Form (IIQ-7)

    Time frame: 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.

  3. Urogenital Distress Inventory-Short Form (UDI-6)

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Betül Taşpınar, Prof.Dr.

CONTACT

[email protected]

0 506 680 44 26

Selçuk Erkılınç, Prof.Dr.

CONTACT

[email protected]

0554 916 69 23

Sponsors and collaborators

Lead sponsor

Izmir Democracy University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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