KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)

November 13, 2017 updated by: Hannu Koistinen, University of Helsinki

The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study

The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00350
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men undergoing surgery for BPH

Exclusion Criteria:

  • Previous prostate surgery
  • Carcinoma of the prostate
  • Neurogenic bladder
  • Bladder carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Green Light Laser
Device: Green light Laser
Laser vs TURP
Device: Transurethral Resection of the Prostate (TURP)
Laser vs TURP
Active Comparator: TURP
Transurethral Resection of the Prostate
Device: Green light Laser
Laser vs TURP
Device: Transurethral Resection of the Prostate (TURP)
Laser vs TURP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPSS (International Prostate Symptom Score)
Time Frame: 12 months
symptom
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAN-PSS (Danish Prostate Symptom Score)
Time Frame: 3, 6 and 12 months
symptom
3, 6 and 12 months
Maximum flow rate (Qmax)
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
Residual urine
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
Length of catheterization
Time Frame: Postoperative recovery
Postoperative recovery
Length of hospital stay
Time Frame: Postoperative recovery
Postoperative recovery
Perioperative bleeding
Time Frame: Time of operation
Time of operation
IIEF (International Index of Erectile Function questionnaire)
Time Frame: 12 months
Erectile Dysfunction
12 months
TRUS (transrectal ultrasound)
Time Frame: 12 months
Measurement of prostate size
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

University of Turku
Oulu University Hospital
Tampere University
South Ostrobothnia Health Care District

Investigators

  • Principal Investigator: Hannu T Koistinen, M.D., Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34/13/03/02/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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