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Clinical Trials/NCT04764903
NCT04764903
Completed
Not Applicable

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

Chinese University of Hong Kong1 site in 1 country246 target enrollmentOctober 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
Chinese University of Hong Kong
Enrollment
246
Locations
1
Primary Endpoint
The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2019
End Date
December 7, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chi Fai NG

Professor

Chinese University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Correlation between nocturia and Central arterial stiffness (CAS)(Baseline)
  • Overall mortality(Through study completion, an average of 2 years)
  • Incidence of acute retention of urine(Through study completion, an average of 2 years)
  • Incidence of requirement of surgical intervention(Through study completion, an average of 2 years)

Study Sites (1)

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