Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong
Location status: Recruiting
Recruiting
NCT Number: NCT07115147
Blue Diode Laser Vaporization for BPH
This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male ≥ 50 years
- Symptomatic BPH
Exclusion criteria
- 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)
Treatment and study plan
Blue diode laser
DeviceAll 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
Primary outcomes
-
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
Secondary outcomes
-
Operation Time
Time frame: Intra-operation
Duration of the operation
-
Need of post operative irrigation
Time frame: Peri-operative period
Need of post operative irrigation
-
Catheter time
Time frame: 1 month, 3 month, 6 month, 12 month
Duration of catheter time in hour since completion of surgery
-
Hospital stay
Time frame: Peri-operative period
Duration of hospital stay in hour since completion of surgery
-
Transfusion rate
Time frame: 1 month
No of patient need transfusion
-
Verbal dysuria score
Time frame: First day after catether removal
It is assesed by a scale from 0-10; the higher score the more worse dysuria
-
Incidence of unplanned clinic okr hospital attendance
Time frame: 90 days since completion of surgery
Number of unplanned clinic or hospital attendance after surgery
-
Patient quality of life
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Assessed with the EQ-5D-5L questionnaire from 0-100, the higher the score the better in quality of life
-
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
Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom
-
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
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
-
Prostate Specific Antigen (PSA) change
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
PSA change after treatment
-
Adverse events (AE) and serious adverse events (SAE) related to the treatment
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
The severity of AE is grade by Clavien-Dindo classification.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Aug 11, 2025
- Registry last updated
- Aug 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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