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

N/AUnknownNCT02075736

University of Helsinki40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

BPH (Benign Prostatic Hyperplasia)

Interventions

KTP laserPROCEDURE

TUR-PPROCEDURE

device

Eligibility

Sex: MALEMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men with anticoagulant medication undergoing surgery for BPH Exclusion Criteria: * Previous prostate surgery * Carcinoma of the prostate * Neurogenic bladder * Bladder carcinoma

Locations (1)

Helsinki University Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Re-bleeding rate requiring hospitalization

Time frame: two months postoperatively

Secondary Outcomes

IPSS (International Prostate Symptom Score)

symptom score

Time frame: 0, 3, 6 and 12 months

DAN-PSS (Danish Prostate 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 one week

Length of hospital stay

Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of one week

Perioperative bleeding

Time frame: Time of operation

IIEF (International Index of Erectile Function) questionnaire

Time frame: 0,12 months

TRUS (transrectal ultrasound)

Time frame: 0, 12 months

Data from ClinicalTrials.gov

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