Overactive BladderNCT07452796
Turkish USIQ: Validity & Reliability
An observational study of Overactive Bladder, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Observational Cohort
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: For your study, based on the information you've provided, participants are volunteer women attending the clinic who meet your inclusion criteria. This means the sample is not randomly selected from the general population, so it is a non-probability sample.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validity and Reliability of the Turkish Version of the Urgency, Severity, and Impact Questionnaire (USIQ)
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Observational Cohort
- Keywords
- Urinary Urgency, Urinary Incontinence, Validation Studies
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational CohortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urgency, Severity and Impact Questionnaire (USIQ)
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.
Measured: At Baseline
Incontinence Impact Questionnaire-Short Form (IIQ-7)
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.
Measured: At baseline
Urogenital Distress Inventory-Short Form (UDI-6)
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.
Measured: At baseline
International Consultation on Incontinence Modular Questionnaire-Overactive Bladder Quality of Life Questionnaire (ICIQ-OABqol / OAB-q)
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Özge Kuşçu, Pt., Principal investigator, İzmir democracy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452796
- Sponsor's protocol ID
- USIQ35
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Urgency, Severity, and Impact Questionnaire (USIQ)
- ClinicalTrials.gov ID
- NCT07452796
- Acronym / sponsor ID
- USIQ35
- Conditions
- Overactive Bladder
- Keywords
- Urinary Urgency, Urinary Incontinence, Validation Studies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Other: Observational CohortWomen diagnosed with Overactive Bladder (OAB) attending the Gynecology and Oncology Clinic at Buca Seyfi Demirsoy Training and Research Hospital who meet inclusion/exclusion criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For your study, based on the information you've provided, participants are volunteer women attending the clinic who meet your inclusion criteria. This means the sample is not randomly selected from the general population, so it is a non-probability sample.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational CohortWomen 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. | Other | Observational Cohort |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Özge Kuşçu, Pt. principal investigator
İzmir democracy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Taşpınar, Prof.Dr. (0 506 680 44 26, betul.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urgency, Severity and Impact Questionnaire (USIQ) (time frame: At Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.