KTP Green Light Prostatectomy Compared With Open Prostatectomy
Phase 4
Completed
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Registration Number
- NCT02072499
- Lead Sponsor
- University of Helsinki
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method IPSS (International Prostate Symptom Score) 12 months symptom score
- Secondary Outcome Measures
Name Time Method IIEF (International Index of Erectile Function questionnaire) 0,12 months Perioperative bleeding Time of operation IPSS (International Prostate Symptom Score) 0, 3 and 6 months Residual urine 0, 3, 6 and 12 months Prostate volume measured with TRUS (transrectal ultrasound) 0, 12 moths Rate of unscheduled hospital contacts 12 months DAN-PSS (Danish Prostate Symptom Score) 0, 3, 6 and 12 months symptom score
Maximum flow rate (Qmax) 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
Trial Locations
- Locations (1)
Helsinki University Hospital
🇫🇮Helsinki, Finland
Helsinki University Hospital🇫🇮Helsinki, Finland