- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452796
Turkish USIQ: Validity & Reliability
Validity and Reliability of the Turkish Version of the Urgency, Severity, and Impact Questionnaire (USIQ)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Betül Taşpınar, Prof.Dr.
- Phone Number: 0 506 680 44 26
- Email: betul.taspinar@idu.edu.tr
Study Contact Backup
- Name: Selçuk Erkılınç, Prof.Dr.
- Phone Number: 0554 916 69 23
- Email: Selcuk.erkilinc@idu.edu.tr
Study Locations
-
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İ̇zmi̇r
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Konak, İ̇zmi̇r, Turkey (Türkiye)
- Betül TAŞPINAR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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At Baseline
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Incontinence Impact Questionnaire-Short Form (IIQ-7)
Time Frame: At baseline
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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.
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At baseline
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Urogenital Distress Inventory-Short Form (UDI-6)
Time Frame: At baseline
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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.
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At baseline
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International Consultation on Incontinence Modular Questionnaire-Overactive Bladder Quality of Life Questionnaire (ICIQ-OABqol / OAB-q)
Time Frame: At baseline
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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.
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At baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Özge Kuşçu, Pt., İzmir democracy
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Urinary Bladder, Overactive
Other Study ID Numbers
- USIQ35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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