BPH (Benign Prostatic Hyperplasia)
Conditions
Brief summary
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients
Interventions
PROCEDUREKTP laser
PROCEDURETUR-P
device
Sponsors
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 with anticoagulant medication undergoing surgery for BPH
Exclusion criteria
* Previous prostate surgery * Carcinoma of the prostate * Neurogenic bladder * Bladder carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-bleeding rate requiring hospitalization | two months postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of catheterization | Participants will be followed for the duration of hospital stay, an expected maximum of one week | — |
| IPSS (International Prostate Symptom Score) | 0, 3, 6 and 12 months | symptom score |
| DAN-PSS (Danish Prostate Symptom Score) | 0, 3, 6 and 12 months | — |
| Maximum flow rate (Qmax) | 0, 3, 6 and 12 months | — |
| Residual urine | 0, 3, 6 and 12 months | — |
| Perioperative bleeding | Time of operation | — |
| IIEF (International Index of Erectile Function) questionnaire | 0,12 months | — |
| TRUS (transrectal ultrasound) | 0, 12 months | — |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected maximum of one week | — |
Countries
Finland
Outcome results
None listed