NCT04722458

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

January 21, 2021

Last Update Submit

May 3, 2023

Conditions

Keywords

Lower urinary tract symptomsPatient reported outcomesQuestionnaire

Outcome Measures

Primary Outcomes (3)

  • LURN SI-29 Questionnaire

    The subscale and total scores for the LURN SI-29 are normalized to a scale from 0 - 100

    3 months

  • 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

  • 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

Study Arms (1)

Patients with Lower urinary tract sypmtoms

Patients with Lower urinary tract sypmtoms over 18 years old will be included to this study

Other: Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)Other: IPSSOther: UDI-6

Interventions

LURN SI-29

Patients with Lower urinary tract sypmtoms
IPSSOTHER

International Prostate Symptom Score

Patients with Lower urinary tract sypmtoms
UDI-6OTHER

Urogenital Distress Inventory

Patients with Lower urinary tract sypmtoms

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lower urinary tract symptoms over 18 will be included

You may qualify if:

  • Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read

You may not qualify if:

  • Patients above 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related 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 (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.

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary Incontinence

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 25, 2021

Study Start

January 28, 2021

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations