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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue light laser Arm | Experimental | 450nm center wavelength blue diode 200W laser is employed for the surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue diode laser | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 1 month, 3 months, 6 months, 12 month |
| Change in urodynamic in uroflowmetry | Change in urodynamic function assessed by uroflowmetry | Baseline, 1 month, 3 months, 6 months, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Operation Time | Duration of the operation | Intra-operation |
| Need of post operative irrigation | Need of post operative irrigation | Peri-operative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ka Fung Peter CHIU, MBChB PhD | Contact | 35052625 | peterchiu@surgery.cuhk.edu.hk | |
| Ka Fung CHIU | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Ka Fung Peter CHIU, MBChB PhD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24136186 | Background | 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. | |
| 22914880 | Background | 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. |
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| Catheter time | Duration of catheter time in hour since completion of surgery | 1 month, 3 month, 6 month, 12 month |
| Hospital stay | Duration of hospital stay in hour since completion of surgery | Peri-operative period |
| Transfusion rate | No of patient need transfusion | 1 month |
| Verbal dysuria score | It is assesed by a scale from 0-10; the higher score the more worse dysuria | First day after catether removal |
| Incidence of unplanned clinic okr hospital attendance | Number of unplanned clinic or hospital attendance after surgery | 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 | 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 | 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 | Baseline, 1 month, 3 months, 6 months, 12 month |
| Prostate Specific Antigen (PSA) change | PSA change after treatment | 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. | Baseline, 1 month, 3 months, 6 months, 12 month |
| 18405761 | Background | 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. |
| 23145474 | Background | 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. |