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

NCT04764903 | Completed

• 1 other identifier: CRE-2019.400
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• Correlation between nocturia and Central arterial stiffness (CAS)

  Baseline

• 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

• Overall mortality

  Through study completion, an average of 2 years

Study Arms (1)

LUTS/Nocturia

Patients with LUTS / Nocturia

Other: No intervention

Interventions

No intervention OTHER

There is no intervention in this study

LUTS/Nocturia

Eligibility Criteria

• Age: 35 Years - 90 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients who presented with lower urinary tract symptom to our centre and assessed in the nurse-led pre-assessment clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (4)

• 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.

  PMID: 18057428 BACKGROUND

• Yee 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.

  PMID: 30083830 BACKGROUND

• Teoh 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.

  PMID: 30648670 BACKGROUND

• Everaert 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.

  PMID: 29767479 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: October 2, 2019
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

HK (1)