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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764903
• Other study ID #: CRE-2019.400
• Status: Completed
• Start date: October 2, 2019
• Est. completion date: December 7, 2020

Study information

• Verified date: February 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Other:
• No intervention
There is no intervention in this study

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Correlation between nocturia and Central arterial stiffness (CAS)	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	Baseline
Secondary	Incidence of acute retention of urine	It is assessed by medical record	Through study completion, an average of 2 years
Secondary	Incidence of requirement of surgical intervention	It is assessed by medical record	Through study completion, an average of 2 years
Secondary	Overall mortality	It is assessed by medical record	Through study completion, an average of 2 years