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Role of PWV on Male LUTS Progression

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ClinicalTrials.gov Identifier: NCT04312074
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Chi Fai NG, Chinese University of Hong Kong

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.


Condition or disease
Lower Urinary Tract Symptoms

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Investigate the Effect of Central Arterial Stiffness on the Progression of Male Bladder Dysfunction, Nocturia and Lower Urinary Tract Symptoms
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : April 30, 2027
Estimated Study Completion Date : July 30, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  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.

  3. 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

  4. 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

  5. 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

  6. Change in medical therapy for BPH [ Time Frame: Baseline, Year 1, Year 2 ]
    It is assessed by medical record

  7. 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

  8. 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312074


Contacts
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Contact: Chi Fai NG, MD 3505-2625 ngcf@surgery.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Chi Fai NG, MD    3505 2625    ngcf@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Chi Fai NG, MD Chinese University of Hong Kong
Publications:

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Responsible Party: Chi Fai NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04312074    
Other Study ID Numbers: CRE-2019.534
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi Fai NG, Chinese University of Hong Kong:
LUTS
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations