Lower Urinary Tract SymptomsNCT04722458
Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms
An observational study of Lower Urinary Tract Symptoms and Urinary Incontinence, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Urinary Tract Symptoms, Urinary Incontinence
- What is being tested?
- Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29), IPSS and UDI-6
- How many people
- 290 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2021to 15 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients with lower urinary tract symptoms over 18 will be included
Who may be able to join
- Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read
Who cannot join
- Patients above 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Lower Urinary Tract Symptoms, Urinary Incontinence
- Being tested
- Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29), IPSS, UDI-6
- Keywords
- Lower urinary tract symptoms, Patient reported outcomes, Questionnaire
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)Other
LURN SI-29
IPSSOther
International Prostate Symptom Score
UDI-6Other
Urogenital Distress Inventory
| Study group | Role | What they receive |
|---|---|---|
| Patients with Lower urinary tract sypmtoms | Patients with Lower urinary tract sypmtoms over 18 years old will be included to this study Receives: Other: Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29); Other: IPSS; Other: UDI-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LURN SI-29 Questionnaire
The subscale and total scores for the LURN SI-29 are normalized to a scale from 0 - 100
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start28 Jan 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Tahra, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722458
- Sponsor's protocol ID
- 2021-0028
- Status last verified
- May 2023
- First submitted
- 21 Jan 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31225927Cella 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.
PubMed 31364922
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of LURN SI-29 Questionnaire Form in Patients With Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT04722458
- Acronym / sponsor ID
- 2021-0028
- Conditions
- Lower Urinary Tract Symptoms, Urinary Incontinence
- Keywords
- Lower urinary tract symptoms, Patient reported outcomes, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 25 Jan 2021 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Lower urinary tract sypmtoms | – | Other: Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29), Other: IPSS, Other: UDI-6Patients with Lower urinary tract sypmtoms over 18 years old will be included to this study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with lower urinary tract symptoms over 18 will be included
Key inclusion criteria (1 listed)
- Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read
Key exclusion criteria (1 listed)
- Patients above 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)LURN SI-29 | Other | Patients with Lower urinary tract sypmtoms |
| IPSSInternational Prostate Symptom Score | Other | Patients with Lower urinary tract sypmtoms |
| UDI-6Urogenital Distress Inventory | Other | Patients with Lower urinary tract sypmtoms |
Primary outcome
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
International Prostate Symptom Score-IPSS
Time frame: 3 months
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.
UROGENITAL DISTRESS INVENTORY- 6
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Results publication: PubMed 31225927Cella 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.
- Results publication: PubMed 31364922Cella 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.
- Individual participant dataSharing planned: No
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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 Lower Urinary Tract Symptoms and Urinary Incontinence, run by Istanbul Medeniyet 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LURN SI-29 Questionnaire (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT04722458, which also lists 2 linked publications.
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 6 May 2023.