Role of PWV on Male LUTS Progression

January 21, 2024 updated by: Chi Fai NG, Chinese University of Hong Kong

To Investigate the Effect of Central Arterial Stiffness on the Progression of Male Bladder Dysfunction, Nocturia and Lower Urinary Tract Symptoms

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

Male-LUTS are prevalent, cause bother and impair quality of life (QoL). Not only does it adversely affect the quality of life of men, it is also closely interrelated with many substantial salient medical conditions. LUTS is strongly associated with ageing. The perpetual increase in aging population in Hong Kong and globally, will reflect and amount to the associated costs and relentlessly surmounting burden on the management of the condition in the future. In light of this, better understanding and management of male-LUTS is important for this major health issue.

Stereotypically, male LUTS have long been attributed to be secondary to prostatic enlargement and resulting from its obstruction. However, increasingly conflicting evidences have suggested that LUTS are often unrelated to the prostate. In fact, more attention has been directed to the dysfunction of the bladder, the reservoir and pump of the voiding system, could also contribute a significant component of LUTS, in both male and female. Bladder dysfunction includes detrusor overactivity (overactive bladder), detrusor underactivity (underactive bladder), as well as other structural or functional abnormalities of the urinary tract and its surrounding tissues. Moreover, there are also many other non-urological conditions which can account for urinary symptoms, especially nocturia.As a result, the current concept of managing male LUTS, has expanded from focusing on the prostate to the bladder and even taking into account the perspective of the patient's medical and health condition as a whole.

There are numerous postulated mechanisms to explain the relationship between these medical conditions and LUTS, including sympathetic overtone, release of growth factors / proinflammation markers to stimulate prostate growth, vascular damage to bladder, etc. However, most of them were reported by cross-sectional studies from which the underlying mechanism cannot be proven and the cause and effect relationships cannot be established. Hence, the time / dose relationship between the proposed mechanisms and the development or progression of male LUTS cannot be confirmed. As a result, the exact mechanism leading to development or progression of male LUTS in patients with CVD / DM / MS is still uncertain.

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.

The objectives of the study are: to study the effects of central arterial stiffness on the progression of male bladder dysfunction, nocturia, storage symptoms and voiding symptoms and to explore the effects of central arterial stiffness on the development of complication(s) and the need of surgical intervention in male patients with lower urinary tract symptoms.

400 adult male subjects aged between 40 and 80 years old with non-neurogenic LUTS will be recruited for the study. Having fulfilled all inclusion and exclusion criteria, subjects will then undergo a series of investigation, including bladder diary and baPWV assessment. BaPWV will be measured by an automated machine using the oscillometric cuff technique.

Follow-up assessment will then be arranged at first and second year following the recruitment. During their re-assessment, medical record will be reviewed and the same set of assessment, including bladder diary and baPWV, will be repeated. The changes in voiding function and those of treatment modalities will be correlated with the baseline baPWV and other parameters.

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in maximal voided volume across the two-year follow-up.
Time Frame: Baseline, Year 1, Year 2
Maximum voided volume was defined as the highest voided volume recorded in bladder diary.
Baseline, Year 1, Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline, Year 1, Year 2
It is assessed by the bladder diary
Baseline, Year 1, Year 2
Incidence of symptom progression
Time Frame: Baseline, Year 1, Year 2
It is assessed by increase in total International Prostate Symptom Scores IPSS) by 4 points from baseline assessment. For IPSS, the total score ranged from 0 to 35. The higher scores mean the symptom is more severe.
Baseline, Year 1, Year 2
Incidence of adverse events related to voiding, including urinary tract infection, retention of urine, obstructive uropathy, bladder stone formation
Time Frame: Baseline, Year 1, Year 2
It is assessed by medical record
Baseline, Year 1, Year 2
Incidence of non-medical intervention for voiding symptom, including surgery, other minimally invasive therapy for prostate
Time Frame: Baseline, Year 1, Year 2
It is assessed by medical record
Baseline, Year 1, Year 2
Incidence of adverse events related to cardiovascular system, such as cerebrovascular accident, myocardial infarction
Time Frame: Baseline, Year 1, Year 2
It is assessed by medical record
Baseline, Year 1, Year 2
Change in medical therapy for BPH
Time Frame: Baseline, Year 1, Year 2
It is assessed by medical record
Baseline, Year 1, Year 2
Correlation between the changes in baPWV and changes in voided volume
Time Frame: Baseline, Year 1, Year 2
Change in baPWV is assessed by Vascular function test, change in voided volume is assessed by bladder diary
Baseline, Year 1, Year 2
Correlation between the changes in baPWV and number of nocturia episode.
Time Frame: Baseline, Year 1, Year 2
Change in baPWV is assessed by Vascular function test, change in voided volume is assessed by bladder diary
Baseline, Year 1, Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2019.534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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