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

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Other: No intervention

• Registration Number: NCT04764903
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2019-10-02
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Status Verified: 2021-02
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 246

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LUTS/Nocturia	No intervention	Patients with LUTS / Nocturia

Primary Outcome Measures

Name	Time	Method
The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)	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)	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)	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 Outcome Measures

Name	Time	Method
Correlation between nocturia and Central arterial stiffness (CAS)	Baseline	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
Overall mortality	Through study completion, an average of 2 years	It is assessed by medical record
Incidence of acute retention of urine	Through study completion, an average of 2 years	It is assessed by medical record
Incidence of requirement of surgical intervention	Through study completion, an average of 2 years	It is assessed by medical record

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong