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

18. februar 2021 opdateret af: Chi Fai NG, Chinese University of Hong Kong

A Retrospective Review of the Association of Baseline Characteristics of Male Patients Presented With Lower Urinary Tract 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

246

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
LUTS/Nocturia
Patients with LUTS / Nocturia
Andet: Ingen indgriben
Der er ingen intervention i denne undersøgelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS)
Tidsramme: 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
Through study completion, an average of 2 years
The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)
Tidsramme: Through study completion, an average of 2 years
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)
Tidsramme: Through study completion, an average of 2 years
It is assessed by medical record
Through study completion, an average of 2 years

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. oktober 2019

Primær færdiggørelse (Faktiske)

7. december 2020

Studieafslutning (Faktiske)

7. december 2020

Datoer for studieregistrering

Først indsendt

16. februar 2021

Først indsendt, der opfyldte QC-kriterier

18. februar 2021

Først opslået (Faktiske)

21. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRE-2019.400

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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