Blue Diode Laser Vaporization for BPH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blue diode laser.
- Who it may be relevant to
- Registry conditions: BPH. Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Blue diode laser
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
Primary outcome measures
- Urinary symptoms measured by International Prostate Symptom Score (IPSS) score [Time frame: Baseline, 1 month, 3 months, 6 months, 12 month]
- Change in urodynamic in uroflowmetry [Time frame: Baseline, 1 month, 3 months, 6 months, 12 month]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital, Chinese University of Hong Kong — Hong Kong
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. PMID 24136186
- Teoh 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. PMID 22914880
- Wei 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. PMID 18405761
- Teng 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. PMID 23145474
Identifiers
NCT: NCT07115147 · CRE2025.162