BPH
Conditions
Brief summary
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
DEVICEBlue 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
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary symptoms measured by International Prostate Symptom Score (IPSS) score | 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 | Baseline, 1 month, 3 months, 6 months, 12 month | Change in urodynamic function assessed by uroflowmetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay | Peri-operative period | Duration of hospital stay in hour since completion of surgery |
| Operation Time | Intra-operation | Duration of the operation |
| Need of post operative irrigation | Peri-operative period | Need of post operative irrigation |
| Verbal dysuria score | 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 | 90 days since completion of surgery | Number of unplanned clinic or hospital attendance after surgery |
| Transfusion rate | 1 month | No of patient need transfusion |
| Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score | 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 | 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 | 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 | Baseline, 1 month, 3 months, 6 months, 12 month | The severity of AE is grade by Clavien-Dindo classification. |
| Patient quality of life | 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 |
| Catheter time | 1 month, 3 month, 6 month, 12 month | Duration of catheter time in hour since completion of surgery |
Countries
Hong Kong
Contacts
Backup ContactKa Fung CHIU
Primary ContactKa Fung Peter CHIU, MBChB PhD
Outcome results
None listed