BPHNCT07115147
Blue Diode Laser Vaporization for BPH
A study testing Blue diode laser in people with BPH, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective data collection of subjects using blude diode laser for the treatment of BPH. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH
- What is being tested?
- Blue diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Jun 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥ 50 years
- Symptomatic BPH
Who cannot join
- Additional procedure is needed e.g. cystolithotripsy, orchidectomy etc2. Known Ca prostate patients
- Patients with history of TURP
- Known Urethral stricture / Bladder stone / Hypercontractile bladder
- Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke) 6. Contraindicated to undergo TURP (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ka Fung CHIU contact
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong
Peter Ka Fung CHIU, MBChB, 852-3505-2625, peterchiu@surgery.cuhk.edu.hk
About this study
This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.
Read the detailed description
This is a prospective single-arm study evaluating the outcome of blue diode laser vaporization. The energy from a 450nm blue laser vaporization will be used for the treatment of BPH. The study period for each patient is 1 year. Recruited subjects will then be followed up at 3 months, 6 months and 12 months after operation. Blood tests, urine tests, ultrasound for prostate volume assessment, uroflowmetry and the same set of questionnaires will be performed again during follow-up for assessing the clinical progress. Any adverse event and unplanned admission will also be documented.
- Conditions
- BPH
- Being tested
- Blue diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue diode laserDevice
All procedures would be performed under spinal or general anaesthesia. Blue diode laser vaporization would be performed according to the standard approach for the obstructing prostate
| Study group | Role | What they receive |
|---|---|---|
| Blue light laser Arm | Experimental | 450nm center wavelength blue diode 200W laser is employed for the surgical procedure Receives: Device: Blue diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Change in urodynamic in uroflowmetry
Change in urodynamic function assessed by uroflowmetry
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Secondary outcomes (12)
Operation Time
Duration of the operation
Measured: Intra-operation
Need of post operative irrigation
Need of post operative irrigation
Measured: Peri-operative period
Catheter time
Duration of catheter time in hour since completion of surgery
Measured: 1 month, 3 month, 6 month, 12 month
Hospital stay
Duration of hospital stay in hour since completion of surgery
Measured: Peri-operative period
Transfusion rate
No of patient need transfusion
Measured: 1 month
Verbal dysuria score
It is assesed by a scale from 0-10; the higher score the more worse dysuria
Measured: First day after catether removal
Incidence of unplanned clinic okr hospital attendance
Number of unplanned clinic or hospital attendance after surgery
Measured: 90 days since completion of surgery
Patient quality of life
Assessed with the EQ-5D-5L questionnaire from 0-100, the higher the score the better in quality of life
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score
Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
Change in MSHQ-EjD-SF questionnaire score (Range from 1-15 for function and and 0-5 for bother). The higher score, the more worse symptom
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Prostate Specific Antigen (PSA) change
PSA change after treatment
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Adverse events (AE) and serious adverse events (SAE) related to the treatment
The severity of AE is grade by Clavien-Dindo classification.
Measured: Baseline, 1 month, 3 months, 6 months, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start26 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BPHStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIU Ka Fung Peter, Chinese University of Hong Kong
- Investigators
- Ka Fung Peter CHIU, MBChB PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115147
- Sponsor's protocol ID
- CRE2025.162
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yee CH, Li JK, Lam HC, Chan ES, Hou SS, Ng CF. The prevalence of lower urinary tract symptoms in a Chinese population, and the correlation with uroflowmetry and disease perception. Int Urol Nephrol. 2014 Apr;46(4):703-10. doi: 10.1007/s11255-013-0586-9. Epub 2013 Oct 18.
PubMed 24136186Teoh JY, Kan CF, Tsui B, Chiu PK, Man CY, Hou SS, Ng CF. Ambulatory care program for patients presenting with acute urinary retention secondary to benign prostatic hyperplasia. Int Urol Nephrol. 2012 Dec;44(6):1593-9. doi: 10.1007/s11255-012-0266-1. Epub 2012 Aug 23.
PubMed 22914880Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in america project: benign prostatic hyperplasia. J Urol. 2008 May;179(5 Suppl):S75-80. doi: 10.1016/j.juro.2008.03.141.
PubMed 18405761Teng J, Zhang D, Li Y, Yin L, Wang K, Cui X, Xu D. Photoselective vaporization with the green light laser vs transurethral resection of the prostate for treating benign prostate hyperplasia: a systematic review and meta-analysis. BJU Int. 2013 Feb;111(2):312-23. doi: 10.1111/j.1464-410X.2012.11395.x. Epub 2012 Nov 13.
PubMed 23145474
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Diode Laser Vaporization for BPH
- ClinicalTrials.gov ID
- NCT07115147
- Acronym / sponsor ID
- CRE2025.162
- Conditions
- BPH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Aug 2025 (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.
This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.
Detailed description
This is a prospective single-arm study evaluating the outcome of blue diode laser vaporization. The energy from a 450nm blue laser vaporization will be used for the treatment of BPH. The study period for each patient is 1 year. Recruited subjects will then be followed up at 3 months, 6 months and 12 months after operation. Blood tests, urine tests, ultrasound for prostate volume assessment, uroflowmetry and the same set of questionnaires will be performed again during follow-up for assessing the clinical progress. Any adverse event and unplanned admission will also be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blue light laser Arm | Experimental | Device: Blue diode laser450nm center wavelength blue diode 200W laser is employed for the surgical procedure |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male ≥ 50 years
- Symptomatic BPH
Key exclusion criteria (4 listed)
- Additional procedure is needed e.g. cystolithotripsy, orchidectomy etc2. Known Ca prostate patients
- Patients with history of TURP
- Known Urethral stricture / Bladder stone / Hypercontractile bladder
- Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke) 6. Contraindicated to undergo TURP (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue diode laserAll procedures would be performed under spinal or general anaesthesia. Blue diode laser vaporization would be performed according to the standard approach for the obstructing prostate | Device | Blue light laser Arm |
Primary outcome
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom
Change in urodynamic in uroflowmetry
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Change in urodynamic function assessed by uroflowmetry
12 secondary outcomes
Operation Time
Time frame: Intra-operation
Need of post operative irrigation
Time frame: Peri-operative period
Catheter time
Time frame: 1 month, 3 month, 6 month, 12 month
Hospital stay
Time frame: Peri-operative period
Transfusion rate
Time frame: 1 month
Verbal dysuria score
Time frame: First day after catether removal
Incidence of unplanned clinic okr hospital attendance
Time frame: 90 days since completion of surgery
Patient quality of life
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Prostate Specific Antigen (PSA) change
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Adverse events (AE) and serious adverse events (SAE) related to the treatment
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 24136186Yee CH, Li JK, Lam HC, Chan ES, Hou SS, Ng CF. The prevalence of lower urinary tract symptoms in a Chinese population, and the correlation with uroflowmetry and disease perception. Int Urol Nephrol. 2014 Apr;46(4):703-10. doi: 10.1007/s11255-013-0586-9. Epub 2013 Oct 18.
- Background: PubMed 22914880Teoh JY, Kan CF, Tsui B, Chiu PK, Man CY, Hou SS, Ng CF. Ambulatory care program for patients presenting with acute urinary retention secondary to benign prostatic hyperplasia. Int Urol Nephrol. 2012 Dec;44(6):1593-9. doi: 10.1007/s11255-012-0266-1. Epub 2012 Aug 23.
- Background: PubMed 18405761Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in america project: benign prostatic hyperplasia. J Urol. 2008 May;179(5 Suppl):S75-80. doi: 10.1016/j.juro.2008.03.141.
- Background: PubMed 23145474Teng J, Zhang D, Li Y, Yin L, Wang K, Cui X, Xu D. Photoselective vaporization with the green light laser vs transurethral resection of the prostate for treating benign prostate hyperplasia: a systematic review and meta-analysis. BJU Int. 2013 Feb;111(2):312-23. doi: 10.1111/j.1464-410X.2012.11395.x. Epub 2012 Nov 13.
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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.
Ka Fung CHIU contact
Ka Fung Peter CHIU, MBChB PhD 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?
A study testing Blue diode laser in people with BPH, 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 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Fung Peter CHIU, MBChB PhD (35052625, peterchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score (time frame: Baseline, 1 month, 3 months, 6 months, 12 month). The study lists 2 primary outcomes in all. 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 NCT07115147, which also lists 4 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 3 Nov 2026.