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Completed

NCT Number: NCT04764903

The Association of Baseline Characteristics of Male Patients Presented With LUTS 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.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

35 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

There is no intervention in this study

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Correlation between nocturia and Central arterial stiffness (CAS)

    Time frame: 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

  2. Incidence of acute retention of urine

    Time frame: Through study completion, an average of 2 years

    It is assessed by medical record

  3. Incidence of requirement of surgical intervention

    Time frame: Through study completion, an average of 2 years

    It is assessed by medical record

  4. Overall mortality

    Time frame: Through study completion, an average of 2 years

    It is assessed by medical record

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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