- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04722458
Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms
May 3, 2023 updated by: Ahmet Tahra, Istanbul Medeniyet University
Turkish Validity and Reliability of LURN SI-29 Questionnaire Form in Patients With Lower Urinary Tract Symptoms
Lower urinary tract symptoms is quite frequent in men and women.
To better understand the the symptoms that characterize lower urinary tract, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).
In this study we aim to validate the LURN-29 score to Turkish language
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
290
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Istanbul Medeniyet University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients with lower urinary tract symptoms over 18 will be included
Description
Inclusion Criteria:
- Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read
Exclusion Criteria:
- Patients above 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Lower urinary tract sypmtoms
Patients with Lower urinary tract sypmtoms over 18 years old will be included to this study
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LURN SI-29
International Prostate Symptom Score
Urogenital Distress Inventory
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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LURN SI-29 Questionnaire
Time Frame: 3 months
|
The subscale and total scores for the LURN SI-29 are normalized to a scale from 0 - 100
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3 months
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International Prostate Symptom Score-IPSS
Time Frame: 3 months
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The IPSS is made up of 7 questions related to voiding symptoms.
A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
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3 months
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UROGENITAL DISTRESS INVENTORY- 6
Time Frame: 3 months
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UDI-6 a six item symptom inventory, specific to symptoms associated with lower urinary tract dysfunction,and combines information on irritative, stress and obstructive/discomfort symptoms
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cella D, Smith AR, Griffith JW, Flynn KE, Bradley CS, Gillespie BW, Kirkali Z, Talaty P, Jelovsek JE, Helfand BT, Weinfurt KP; LURN Study Group. A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire. Neurourol Urodyn. 2019 Aug;38(6):1751-1759. doi: 10.1002/nau.24067. Epub 2019 Jun 21.
- Cella D, Smith AR, Griffith JW, Kirkali Z, Flynn KE, Bradley CS, Jelovsek JE, Gillespie BW, Helfand BT, Talaty P, Weinfurt KP; LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020 Jan;203(1):164-170. doi: 10.1097/JU.0000000000000465. Epub 2019 Jul 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2021
Primary Completion (Actual)
May 15, 2021
Study Completion (Actual)
May 15, 2021
Study Registration Dates
First Submitted
January 21, 2021
First Submitted That Met QC Criteria
January 21, 2021
First Posted (Actual)
January 25, 2021
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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