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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04722458
Other study ID # 2021-0028
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 28, 2021
Est. completion date May 15, 2021

Study information

Verified date May 2023
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)
LURN SI-29
IPSS
International Prostate Symptom Score
UDI-6
Urogenital Distress Inventory

Locations

Country Name City State
Turkey Istanbul Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 — View Citation

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 Ja — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary LURN SI-29 Questionnaire The subscale and total scores for the LURN SI-29 are normalized to a scale from 0 - 100 3 months
Primary International Prostate Symptom Score-IPSS 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. 3 months
Primary UROGENITAL DISTRESS INVENTORY- 6 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 3 months
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