BPH (Benign Prostatic Hyperplasia)
Conditions
Brief summary
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.
Interventions
DEVICEGreen light Laser
Laser vs TURP
Laser vs TURP
Sponsors
University of Turku
Tampere University
South Ostrobothnia Health Care District
Oulu University Hospital
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Men undergoing surgery for BPH
Exclusion criteria
* Previous prostate surgery * Carcinoma of the prostate * Neurogenic bladder * Bladder carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPSS (International Prostate Symptom Score) | 12 months | symptom |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TRUS (transrectal ultrasound) | 12 months | Measurement of prostate size |
| DAN-PSS (Danish Prostate Symptom Score) | 3, 6 and 12 months | symptom |
| Maximum flow rate (Qmax) | 3, 6 and 12 months | — |
| IIEF (International Index of Erectile Function questionnaire) | 12 months | Erectile Dysfunction |
| Length of catheterization | Postoperative recovery | — |
| Length of hospital stay | Postoperative recovery | — |
| Perioperative bleeding | Time of operation | — |
| Residual urine | 3, 6 and 12 months | — |
Countries
Finland
Outcome results
None listed