Rheumatoid ArthritisNCT07916623
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Rheumatoid Arthritis (RA), run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Rheumatoid Arthritis (RA), Urinary Incontinence (UI)
- How many people
- 393 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2026to 11 Nov 2026
- How long will I take part?
- 1 Day
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Ege University Faculty Of Medicine
Who may be able to join
- 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.
Who cannot join
- 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 who have previously undergone surgery for urinary incontinence treatment.
- Those with Sjögren's syndrome.
- Those with diagnosed diabetes mellitus (DM).
- Those who have received radiotherapy to the pelvic region.
- Those who are pregnant or suspect they are pregnant.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, Bornova, 35100
About this study
Official title: Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis: A Multicenter Controlled Cross-Sectional Study
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.
- Keywords
- rheumatoid arthritis, urinary incontinence
- Medical subject headings
- Arthritis, Rheumatoid, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rheumatoid arthritis | Not described | |
| healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of treatment at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start6 Jan 2026
- Primary completion10 Jul 2026
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 393 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Yıldız Güvercin, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916623
- Sponsor's protocol ID
- 25-12.1T/24
- Status last verified
- Jan 2026
- First submitted
- 11 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis: A Multicenter Controlled Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07916623
- Acronym / sponsor ID
- 25-12.1T/24
- Keywords
- rheumatoid arthritis, urinary incontinence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 4 Nov 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis | – | – |
| healthy | – | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Ege University Faculty Of Medicine
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 who have previously undergone surgery for urinary incontinence treatment.
- Those with Sjögren's syndrome.
- Those with diagnosed diabetes mellitus (DM).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
Time frame: From enrollment to the end of treatment at 1 day
* 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
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: From enrollment to the end of treatment at 1 day
* 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.
The Overactive Bladder Symptom Score (OABSS)
Time frame: From enrollment to the end of treatment at 1 day
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).
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatoid Arthritis and Rheumatoid Arthritis (RA), run by Ege 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (time frame: From enrollment to the end of treatment at 1 day). The study lists 3 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 4 Nov 2026.