An observational study in Rheumatoid Arthritis, Rheumatoid Arthritis (RA) and Urinary Incontinence (UI), sponsored by Ege University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ege University · Observational
The primary aim of this study is to compare the frequency and severity of overactive bladder (OAB) symptoms and urinary incontinence (UI) in women diagnosed with Rheumatoid Arthritis (RA) with a control group of healthy women. Secondary aims are to examine the relationships between the presence of OAB symptoms and UI in RA patients and demographic characteristics, disease duration, and disease activity; and to evaluate the impact of these symptoms on the quality of life of RA patients and healthy controls.
This multicenter, cross-sectional study will include women diagnosed with RA and healthy women of similar age. The sample size was calculated using G*Power 3.1 software with 80% power and a 5% alpha margin of error, assuming a prevalence of lower urinary tract symptoms of 60% in the RA group and 40% in the control group. A minimum of 95 participants/group was determined to detect a 20% difference between the two groups. Subgroup analyses were planned to include a total of 900 participants, with 450 participants from each group, to balance inter-center heterogeneity and compensate for potential data loss. Data collection tools included demographic information (age, body mass index, menopausal status, smoking and alcohol use, education level, occupation, and number of births), disease duration in the RA group, and disease activity (DAS-28). The Overactive Bladder Symptom Score (OABSS), the International Incontinence Counseling Questionnaire - Short Form (ICIQ-SF), and the Incontinence Impact Questionnaire (IIQ-7) scales were used to assess OAB symptoms (frequent urination, nocturia, urge incontinence) and quality of life with UI. Dependent variables were OAB symptoms (frequent urination, nocturia, urge incontinence) and quality of life, while independent variables were demographic characteristics, RA disease duration, DAS-28, and the group variable. Data will be analyzed using SPSS software; in addition to descriptive statistics, independent samples t-test or Mann-Whitney U test, Chi-square test, correlation analyses, and logistic regression for AAM symptoms will be applied according to the appropriate distribution. The significance level will be accepted as p\<0.05.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 393 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.
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Ege University Faculty Of Medicine
Inclusion Criteria:
Inclusion Criteria (Control Group):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
* Minimum value: 0 * Maximum value: 21 * Score interpretation: Higher scores mean a worse outcome (greater urinary incontinence severity and higher negative impact on quality of life
Time frame: From enrollment to the end of treatment at 1 day
Incontinence Impact Questionnaire Short Form (IIQ-7)
* Minimum Value: 0 * Maximum Value: 100 * Outcome Meaning: Higher scores indicate a worse outcome (greater symptom burden and a more significant negative impact on health-related quality of life). Conversely, lower scores mean the condition is causing less distress or disruption.
Time frame: From enrollment to the end of treatment at 1 day
The Overactive Bladder Symptom Score (OABSS)
The Overactive Bladder Symptom Score (OABSS) ranges from a minimum of 0 to a maximum of 15 points. A higher score indicates a worse outcome (more severe symptoms).
Time frame: From enrollment to the end of treatment at 1 day
Plan to share: Yes
Supporting information: Study protocol, Clinical study report
Ran from Jan 2026 to primary completion in Jul 2026, 6 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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