Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Participants enrolled: 393
• From 6 Jan 2026 to the primary completion date, 10 Jul 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

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Who the study is looking for

Age in the registry: 20 years to 60 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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