KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients

Not Applicable

Active, not recruiting

• Conditions: BPH (Benign Prostatic Hyperplasia)
• Interventions: Procedure: KTP laser; Procedure: TUR-P

• Registration Number: NCT02075736
• Lead Sponsor: University of Helsinki

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-03-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Men with anticoagulant medication undergoing surgery for BPH

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 laser	KTP laser	device
TUR-P	TUR-P	device

Primary Outcome Measures

Name	Time	Method
Re-bleeding rate requiring hospitalization	two months postoperatively

Secondary Outcome Measures

Name	Time	Method
Length of catheterization	Participants will be followed for the duration of hospital stay, an expected maximum of one week
Residual urine	0, 3, 6 and 12 months
Length of hospital stay	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
Maximum flow rate (Qmax)	0, 3, 6 and 12 months
DAN-PSS (Danish Prostate Symptom Score)	0, 3, 6 and 12 months
IIEF (International Index of Erectile Function) questionnaire	0,12 months
TRUS (transrectal ultrasound)	0, 12 months
Perioperative bleeding	Time of operation

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland