Role of PWV on Male LUTS Progression

NCT04312074 | Terminated

• 1 other identifier: CRE-2019.534
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Male lower urinary tract symptoms (LUTS) is exceedingly common in the general population. Stereotypically, male LUTS have long been attributed to the prostate. However, recent attention has been directed to the bladder dysfunction as a cause of LUTS. LUTS also shares has a close relationship with cardiovascular diseases (CVD), diabetes and metabolic syndrome. These problems could lead to various end-organ damages, via diverse mechanisms, with central arterial stiffness (CAS) is one of them. Amongst the abundant methods for the measurement of CAS, brachial-ankle Pulse Wave Velocity (baPWV) has been shown to be a simple and an accurate approach and is widely used clinically. From investigators' preliminary work, investigators had shown that baPWV is correlated with the baseline voiding function and voided volume. Investigators postulate that CVD and related diseases would increase CAS, which in turn could cause insult to the urinary bladder. Inevitably, it would lead to bladder dysfunction and LUTS. In the wake of this postulation, a study to investigate the relationship of CAS and the progression of male LUTS is proposed.

Conditions

Lower Urinary Tract Symptoms

Keywords

LUTS

Outcome Measures

Primary Outcomes (1)

• Changes in maximal voided volume across the two-year follow-up.

  Maximum voided volume was defined as the highest voided volume recorded in bladder diary.

  Baseline, Year 1, Year 2

Secondary Outcomes (8)

• The number of times an individual passes urine during their main sleep period, from the time they have fallen asleep up to the intention to rise from that period.

  Baseline, Year 1, Year 2

• Incidence of symptom progression

  Baseline, Year 1, Year 2

• Incidence of adverse events related to voiding, including urinary tract infection, retention of urine, obstructive uropathy, bladder stone formation

  Baseline, Year 1, Year 2

• Incidence of non-medical intervention for voiding symptom, including surgery, other minimally invasive therapy for prostate

  Baseline, Year 1, Year 2

• Incidence of adverse events related to cardiovascular system, such as cerebrovascular accident, myocardial infarction

  Baseline, Year 1, Year 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400 adult male subjects aged between 40 and 80 years old with non-neurogenic LUTS will be recruited for the study.

You may qualify if:

• Adult male subject aged between 40 and 80 years old.
• Able to consent to the study

You may not qualify if:

• Have LUTS secondary to urethral stricture, neurogenic bladder or other structural abnormality
• Have known history of prostate cancer or bladder cancer
• Have been using 5α-reductase inhibitors for the management of male LUTS
• Have history of previous lower urinary tract (bladder, prostate, urethra) surgery or scheduled to have upcoming surgery
• Have history of other pelvic surgery that may affect voiding
• Have bladder stones or an active urinary tract infection within 8 weeks prior to recruitment for the study
• Subject is unable to complete questionnaires adopted in the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (10)

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  PMID: 30655460 BACKGROUND

• 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

• Bouwman II, Blanker MH, Schouten BW, Bohnen AM, Nijman RJ, van der Heide WK, Bosch JL. Are lower urinary tract symptoms associated with cardiovascular disease in the Dutch general population? Results from the Krimpen study. World J Urol. 2015 May;33(5):669-76. doi: 10.1007/s00345-014-1398-y. Epub 2014 Sep 25.

  PMID: 25253653 BACKGROUND

• Gacci M, Corona G, Sebastianelli A, Serni S, De Nunzio C, Maggi M, Vignozzi L, Novara G, McVary KT, Kaplan SA, Gravas S, Chapple C. Male Lower Urinary Tract Symptoms and Cardiovascular Events: A Systematic Review and Meta-analysis. Eur Urol. 2016 Nov;70(5):788-796. doi: 10.1016/j.eururo.2016.07.007. Epub 2016 Jul 20.

  PMID: 27451136 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

• Victor RG, Li N, Blyler CA, Mason OR, Chang LC, Moy NPB, Rashid MA, Weiss JP, Handler J, Brettler JW, Sagisi MB, Rader F, Elashoff RM. Nocturia as an Unrecognized Symptom of Uncontrolled Hypertension in Black Men Aged 35 to 49 Years. J Am Heart Assoc. 2019 Mar 5;8(5):e010794. doi: 10.1161/JAHA.118.010794.

  PMID: 30827133 BACKGROUND

• Tsuchikura S, Shoji T, Kimoto E, Shinohara K, Hatsuda S, Koyama H, Emoto M, Nishizawa Y. Brachial-ankle pulse wave velocity as an index of central arterial stiffness. J Atheroscler Thromb. 2010 Jun 30;17(6):658-65. doi: 10.5551/jat.3616. Epub 2010 May 13.

  PMID: 20467192 BACKGROUND

• Uzun H, Cicek Y, Kocaman SA, Durakoglugil ME, Zorba OU. Increased pulse-wave velocity and carotid intima-media thickness in patients with lower urinary tract symptoms. Scand J Urol. 2013 Oct;47(5):393-8. doi: 10.3109/21681805.2013.780185. Epub 2013 Mar 26.

  PMID: 23528066 BACKGROUND

• Yamaguchi O. Latest treatment for lower urinary tract dysfunction: therapeutic agents and mechanism of action. Int J Urol. 2013 Jan;20(1):28-39. doi: 10.1111/iju.12008. Epub 2012 Nov 28.

  PMID: 23190275 BACKGROUND

• Lombardo R, Tubaro A, Burkhard F. Nocturia: The Complex Role of the Heart, Kidneys, and Bladder. Eur Urol Focus. 2020 May 15;6(3):534-536. doi: 10.1016/j.euf.2019.07.007. Epub 2019 Aug 5.

  PMID: 31395515 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: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 18, 2020
• Study Start: May 11, 2020
• Primary Completion: October 20, 2023
• Study Completion: December 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)