Lower Urinary Tract SymptomsNCT04764903
The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes
An observational study of Lower Urinary Tract Symptoms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom presented in urological clinic. Male LUTS could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc. Read more about this study
- Who is it for?
- Ages 35 to 90 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 246 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2019to 7 Dec 2020
- 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 35 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients who presented with lower urinary tract symptom to our centre and assessed in the nurse-led pre-assessment clinic
Who may be able to join
- Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre.
Who cannot join
- Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Review of the Association of Baseline Characteristics of Male Patients Presented With Lower Urinary Tract and Long Term Clinical Outcomes
Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom presented in urological clinic. Male LUTS could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc. Also male LUTS has shown to have close relationship with metabolic and cardiovascular conditions. Because of the increasing evidences to suggest a close relationship of cardiovascular condition and metabolic problems and male LUTS, this is a study to retrospective review of the patients assessed in this urology clinic and have a more in-depth assessment of the relationship of the baseline characteristics of these medical conditions with the presenting symptoms, as well as the long term urological and overall clinical outcomes of these patients.
Read the detailed description
This is a retrospective study.Male patients who presented with lower urinary tract symptom to our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the study. This study will be conducted by observation; that is, data will be captured from medical records and central medical system (CMS), but patients will not be contacted. All the demographic and medical background, as well as investigations performed during the assessment including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse, vascular assessment and blood result will be collected. Follow-up data including usage of medication, clinical outcomes (such as development of urinary retention, cardiovascular events, need of surgical intervention, mortality etc.) will be captured from the medical records.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- No intervention
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| LUTS/Nocturia | Patients with LUTS / Nocturia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS)
Major adverse cardiovascular events such as myocardial infraction, ischemic heart disease, heart failure, coronary angioplasty etc. in male patients with LUTS. It is assessed by medical record
Measured: Through study completion, an average of 2 years
The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)
It is assessed by medical record
Measured: Through study completion, an average of 2 years
The overall prevalence of dyslipidaemia in male patients presented with lower urinary tract symptoms (LUTS)
It is assessed by medical record
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Correlation between nocturia and Central arterial stiffness (CAS)
Nocturia is assessed by International Prostate Symptom Score Question 7, high value means worser nocturia; CAS is assessed by brachial-ankle PWV (baPWV), the value >1800cm/sec is highly associated with development of MACE
Measured: Baseline
Incidence of acute retention of urine
It is assessed by medical record
Measured: Through study completion, an average of 2 years
Incidence of requirement of surgical intervention
It is assessed by medical record
Measured: Through study completion, an average of 2 years
Overall mortality
It is assessed by medical record
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start2 Oct 2019
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Fai NG, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764903
- Sponsor's protocol ID
- CRE-2019.400
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng CF, Wong A, Li ML, Chan SY, Mak SK, Wong WS. The prevalence of cardiovascular risk factors in male patients who have lower urinary tract symptoms. Hong Kong Med J. 2007 Dec;13(6):421-6.
PubMed 18057428Yee CH, Yip JSY, Cheng NMY, Kwan CH, Li KM, Teoh JYC, Chiu PKF, Wong JH, Chan ESY, Chan CK, Hou SSM, Ng CF. The cardiovascular risk factors in men with lower urinary tract symptoms. World J Urol. 2019 Apr;37(4):727-733. doi: 10.1007/s00345-018-2432-2. Epub 2018 Aug 6.
PubMed 30083830Teoh JY, Chan CK, Wang MH, Leung CH, Chan ES, Chiu PK, Yee CH, Wong HM, Hou SS, Ng CF. Transurethral resection of prostate for acute urinary retention is linked to shorter survival in younger men. Asian J Androl. 2019 Sep-Oct;21(5):468-472. doi: 10.4103/aja.aja_101_18.
PubMed 30648670Everaert K, Anderson P, Wood R, Andersson FL, Holm-Larsen T. Nocturia is more bothersome than daytime LUTS: Results from an Observational, Real-life Practice Database including 8659 European and American LUTS patients. Int J Clin Pract. 2018 Jun;72(6):e13091. doi: 10.1111/ijcp.13091. Epub 2018 May 16.
PubMed 29767479
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of the Association of Baseline Characteristics of Male Patients Presented With Lower Urinary Tract and Long Term Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04764903
- Acronym / sponsor ID
- CRE-2019.400
- Conditions
- Lower Urinary Tract Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 21 Feb 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.
Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom presented in urological clinic. Male LUTS could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc. Also male LUTS has shown to have close relationship with metabolic and cardiovascular conditions. Because of the increasing evidences to suggest a close relationship of cardiovascular condition and metabolic problems and male LUTS, this is a study to retrospective review of the patients assessed in this urology clinic and have a more in-depth assessment of the relationship of the baseline characteristics of these medical conditions with the presenting symptoms, as well as the long term urological and overall clinical outcomes of these patients.
Detailed description
This is a retrospective study.Male patients who presented with lower urinary tract symptom to our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the study. This study will be conducted by observation; that is, data will be captured from medical records and central medical system (CMS), but patients will not be contacted. All the demographic and medical background, as well as investigations performed during the assessment including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse, vascular assessment and blood result will be collected. Follow-up data including usage of medication, clinical outcomes (such as development of urinary retention, cardiovascular events, need of surgical intervention, mortality etc.) will be captured from the medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUTS/Nocturia | – | Other: No interventionPatients with LUTS / Nocturia |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients who presented with lower urinary tract symptom to our centre and assessed in the nurse-led pre-assessment clinic
Key inclusion criteria (1 listed)
- Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre.
Key exclusion criteria (1 listed)
- Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease
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 |
|---|---|---|
| No interventionThere is no intervention in this study | Other | LUTS/Nocturia |
Primary outcome
The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS)
Time frame: Through study completion, an average of 2 years
Major adverse cardiovascular events such as myocardial infraction, ischemic heart disease, heart failure, coronary angioplasty etc. in male patients with LUTS. It is assessed by medical record
The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)
Time frame: Through study completion, an average of 2 years
It is assessed by medical record
The overall prevalence of dyslipidaemia in male patients presented with lower urinary tract symptoms (LUTS)
Time frame: Through study completion, an average of 2 years
It is assessed by medical record
4 secondary outcomes
Correlation between nocturia and Central arterial stiffness (CAS)
Time frame: Baseline
Incidence of acute retention of urine
Time frame: Through study completion, an average of 2 years
Incidence of requirement of surgical intervention
Time frame: Through study completion, an average of 2 years
Overall mortality
Time frame: Through study completion, an average of 2 years
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 21 Feb 2021.
- Background: PubMed 18057428Ng CF, Wong A, Li ML, Chan SY, Mak SK, Wong WS. The prevalence of cardiovascular risk factors in male patients who have lower urinary tract symptoms. Hong Kong Med J. 2007 Dec;13(6):421-6.
- Background: PubMed 30083830Yee CH, Yip JSY, Cheng NMY, Kwan CH, Li KM, Teoh JYC, Chiu PKF, Wong JH, Chan ESY, Chan CK, Hou SSM, Ng CF. The cardiovascular risk factors in men with lower urinary tract symptoms. World J Urol. 2019 Apr;37(4):727-733. doi: 10.1007/s00345-018-2432-2. Epub 2018 Aug 6.
- Background: PubMed 30648670Teoh JY, Chan CK, Wang MH, Leung CH, Chan ES, Chiu PK, Yee CH, Wong HM, Hou SS, Ng CF. Transurethral resection of prostate for acute urinary retention is linked to shorter survival in younger men. Asian J Androl. 2019 Sep-Oct;21(5):468-472. doi: 10.4103/aja.aja_101_18.
- Background: PubMed 29767479Everaert K, Anderson P, Wood R, Andersson FL, Holm-Larsen T. Nocturia is more bothersome than daytime LUTS: Results from an Observational, Real-life Practice Database including 8659 European and American LUTS patients. Int J Clin Pract. 2018 Jun;72(6):e13091. doi: 10.1111/ijcp.13091. Epub 2018 May 16.
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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.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
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, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 21 Feb 2021. 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 Hong Kong. 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?
The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS) (time frame: Through study completion, an average of 2 years). 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 NCT04764903, which also lists 4 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 21 Feb 2021.