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 open prostatectomy when treating benign prostatic hyperplasia (BPH).
Interventions
Sponsors
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Men undergoing surgery for BPH with prostate size more than 100cc
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 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative bleeding | Time of operation | — |
| IIEF (International Index of Erectile Function questionnaire) | 0,12 months | — |
| Prostate volume measured with TRUS (transrectal ultrasound) | 0, 12 moths | — |
| Rate of unscheduled hospital contacts | 12 months | — |
| IPSS (International Prostate Symptom Score) | 0, 3 and 6 months | — |
| Maximum flow rate (Qmax) | 0, 3, 6 and 12 months | — |
| Residual urine | 0, 3, 6 and 12 months | — |
| Length of catheterization | Participants will be followed for the duration of hospital stay, an expected maximum of two weeks | — |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected maximum of two weeks | — |
| DAN-PSS (Danish Prostate Symptom Score) | 0, 3, 6 and 12 months | symptom score |
Countries
Finland
Outcome results
None listed