A Phase 4 interventional study of KTP Green Light Prostatectomy and Green Light in BPH (Benign Prostatic Hyperplasia), sponsored by University of Helsinki. Completed at 1 site in Finland. Open to male participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by University of Helsinki · Phase 4, Interventional, and Treatment
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).
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 40 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device
Procedure: KTP Green Light Prostatectomy · Device: Green Light
Surgical procedure
Procedure: Open prostatectomy
IPSS (International Prostate Symptom Score)
symptom score
Time frame: 12 months
DAN-PSS (Danish Prostate Symptom Score)
symptom score
Time frame: 0, 3, 6 and 12 months
Maximum flow rate (Qmax)
Time frame: 0, 3, 6 and 12 months
Residual urine
Time frame: 0, 3, 6 and 12 months
Length of catheterization
Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Perioperative bleeding
Time frame: Time of operation
IIEF (International Index of Erectile Function questionnaire)
Time frame: 0,12 months
Prostate volume measured with TRUS (transrectal ultrasound)
Time frame: 0, 12 moths
Rate of unscheduled hospital contacts
Time frame: 12 months
IPSS (International Prostate Symptom Score)
Time frame: 0, 3 and 6 months
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Helsinki