KTP Green Light Prostatectomy Compared With Open Prostatectomy

Phase 4

Completed

• Conditions: BPH (Benign Prostatic Hyperplasia)
• Interventions: Procedure: Open prostatectomy; Procedure: KTP Green Light Prostatectomy; Device: Green Light

• 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

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-26
• Primary Completion: 2017-06
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14

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

Arm && Interventions

Group	Intervention	Description
KTP Green Light Prostatectomy	Green Light	Device
Open prostatectomy	Open prostatectomy	Surgical procedure
KTP Green Light Prostatectomy	KTP Green Light Prostatectomy	Device

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