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NCT07916623Fut, nem toboroz

Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis

Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis: A Multicenter Controlled Cross-Sectional Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 4.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Megfigyeléses
Résztvevők száma
393 (tényleges)
Első benyújtás
2026. okt. 11.
Kezdés
2026. jan. 6.
Elsődleges befejezés
2026. júl. 10.
Fő szponzor
Ege University
NCT-szám
NCT07916623

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 393
  • 2026. jan. 6. és az elsődleges befejezés (2026. júl. 10.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Those who have previously undergone surgery for urinary incontinence treatment.
  • Those who have received radiotherapy to the pelvic region.

Más betegség

  • Those with active urinary tract infections.
  • Those with neurogenic bladder or a known neurological disease that may cause it (e.g., Multiple Sclerosis, Parkinson's disease).
  • Those with Sjögren's syndrome.
  • Those with diagnosed diabetes mellitus (DM).

Egyéb

  • Those who are pregnant or suspect they are pregnant.

Kiket keres a vizsgálat

  • Being between 20 and 60 years of age.
  • Being female.
  • Agreeing to participate in the study and signing the informed consent form.
  • Having a definitive diagnosis of Rheumatoid Arthritis (RA) according to ACR/EULAR 2010 criteria.
  • Healthy women without a history of RA or other chronic inflammatory disease.
  • Being matched with the RA group in terms of age and body mass index.
  • Agreeing to participate in the study and signing the informed consent form.

Életkor a regiszterben: 20 év – 60 év · Nem: csak nők · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Ege University Faculty of Medicine
Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát
IzmirTurkey (Türkiye)Ismeretlen állapot

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