This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGUrinary 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
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Change in urodynamic in uroflowmetry
Change in urodynamic function assessed by uroflowmetry
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Operation Time
Duration of the operation
Time frame: Intra-operation
Need of post operative irrigation
Need of post operative irrigation
Time frame: Peri-operative period
Catheter time
Duration of catheter time in hour since completion of surgery
Time frame: 1 month, 3 month, 6 month, 12 month
Hospital stay
Duration of hospital stay in hour since completion of surgery
Time frame: Peri-operative period
Transfusion rate
No of patient need transfusion
Time frame: 1 month
Verbal dysuria score
It is assesed by a scale from 0-10; the higher score the more worse dysuria
Time frame: First day after catether removal
Ka Fung CHIU
CONTACT
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Incidence of unplanned clinic okr hospital attendance
Number of unplanned clinic or hospital attendance after surgery
Time frame: 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
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
Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom
Time frame: 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
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month
Prostate Specific Antigen (PSA) change
PSA change after treatment
Time frame: 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.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 month