Lower Urinary Tract SymptomsNCT04312074
Role of PWV on Male LUTS Progression
An observational study of Lower Urinary Tract Symptoms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 159 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 May 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 400 adult male subjects aged between 40 and 80 years old with non-neurogenic LUTS will be recruited for the study.
Who may be able to join
- Adult male subject aged between 40 and 80 years old.
- Able to consent to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- LUTS
- Medical subject headings
- Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
It is assessed by the bladder diary
Measured: Baseline, Year 1, Year 2
Incidence of symptom progression
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.
Measured: Baseline, Year 1, Year 2
Incidence of adverse events related to voiding, including urinary tract infection, retention of urine, obstructive uropathy, bladder stone formation
It is assessed by medical record
Measured: Baseline, Year 1, Year 2
Incidence of non-medical intervention for voiding symptom, including surgery, other minimally invasive therapy for prostate
It is assessed by medical record
Measured: Baseline, Year 1, Year 2
Incidence of adverse events related to cardiovascular system, such as cerebrovascular accident, myocardial infarction
It is assessed by medical record
Measured: Baseline, Year 1, Year 2
Change in medical therapy for BPH
It is assessed by medical record
Measured: Baseline, Year 1, Year 2
Correlation between the changes in baPWV and changes in voided volume
Change in baPWV is assessed by Vascular function test, change in voided volume is assessed by bladder diary
Measured: Baseline, Year 1, Year 2
Correlation between the changes in baPWV and number of nocturia episode.
Change in baPWV is assessed by Vascular function test, change in voided volume is assessed by bladder diary
Measured: Baseline, Year 1, Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start11 May 2020
- Primary completion20 Oct 2023
- Study completion31 Dec 2023
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Fai NG, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312074
- Sponsor's protocol ID
- CRE-2019.534
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yee CH, Chan CK, Teoh JYC, Chiu PKF, Wong JHM, Chan ESY, Hou SSM, Ng CF. Survey on prevalence of lower urinary tract symptoms in an Asian population. Hong Kong Med J. 2019 Feb;25(1):13-20. doi: 10.12809/hkmj187502. Epub 2019 Jan 18.
PubMed 30655460Ng 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.
PubMed 18057428Bouwman 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.
PubMed 25253653Gacci 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.
PubMed 27451136Yee 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.
PubMed 30083830Victor 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.
PubMed 30827133Tsuchikura 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.
PubMed 20467192Uzun 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.
PubMed 23528066Yamaguchi 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.
PubMed 23190275Lombardo 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.
PubMed 31395515
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect of Central Arterial Stiffness on the Progression of Male Bladder Dysfunction, Nocturia and Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT04312074
- Acronym / sponsor ID
- CRE-2019.534
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- LUTS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No funding
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 adult male subjects aged between 40 and 80 years old with non-neurogenic LUTS will be recruited for the study.
Key inclusion criteria (2 listed)
- Adult male subject aged between 40 and 80 years old.
- Able to consent to the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
Incidence of symptom progression
Time frame: 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
Incidence of non-medical intervention for voiding symptom, including surgery, other minimally invasive therapy for prostate
Time frame: 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
Change in medical therapy for BPH
Time frame: Baseline, Year 1, Year 2
Correlation between the changes in baPWV and changes in voided volume
Time frame: Baseline, Year 1, Year 2
Correlation between the changes in baPWV and number of nocturia episode.
Time frame: Baseline, Year 1, Year 2
Results and safety
The study was stopped early (reason given: No funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 30655460Yee CH, Chan CK, Teoh JYC, Chiu PKF, Wong JHM, Chan ESY, Hou SSM, Ng CF. Survey on prevalence of lower urinary tract symptoms in an Asian population. Hong Kong Med J. 2019 Feb;25(1):13-20. doi: 10.12809/hkmj187502. Epub 2019 Jan 18.
- Background: PubMed 18057428Ng 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.
- Background: PubMed 25253653Bouwman 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.
- Background: PubMed 27451136Gacci 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.
- Background: PubMed 30083830Yee 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.
- Background: PubMed 30827133Victor 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.
- Background: PubMed 20467192Tsuchikura 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.
- Background: PubMed 23528066Uzun 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.
- Background: PubMed 23190275Yamaguchi 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.
- Background: PubMed 31395515Lombardo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in maximal voided volume across the two-year follow-up. (time frame: Baseline, Year 1, Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312074, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.