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The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes

A Retrospective Review of the Association of Baseline Characteristics of Male Patients Presented With Lower Urinary Tract and Long Term Clinical Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04764903
Enrollment
246
Registered
2021-02-21
Start date
2019-10-02
Completion date
2020-12-07
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms

Brief 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. 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.

Interventions

OTHERNo intervention

There is no intervention in this study

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
35 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre.

Exclusion criteria

* Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease

Design outcomes

Primary

MeasureTime frameDescription
The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS)Through study completion, an average of 2 yearsMajor 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)Through study completion, an average of 2 yearsIt is assessed by medical record
The overall prevalence of dyslipidaemia in male patients presented with lower urinary tract symptoms (LUTS)Through study completion, an average of 2 yearsIt is assessed by medical record

Secondary

MeasureTime frameDescription
Correlation between nocturia and Central arterial stiffness (CAS)BaselineNocturia 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
Overall mortalityThrough study completion, an average of 2 yearsIt is assessed by medical record
Incidence of acute retention of urineThrough study completion, an average of 2 yearsIt is assessed by medical record
Incidence of requirement of surgical interventionThrough study completion, an average of 2 yearsIt is assessed by medical record

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026