KTP Green Light Prostatectomy Compared With Open Prostatectomy

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

The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, 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 open prostatectomy when treating benign prostatic hyperplasia (BPH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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, 00029
        • 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 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 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
Experimental: KTP Green Light Prostatectomy
Device
Procedure: KTP Green Light Prostatectomy
Device: Green Light
Active Comparator: Open prostatectomy
Surgical procedure
Procedure: Open prostatectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative bleeding
Time Frame: Time of operation
Time of operation
Maximum flow rate (Qmax)
Time Frame: 0, 3, 6 and 12 months
0, 3, 6 and 12 months
Residual urine
Time Frame: 0, 3, 6 and 12 months
0, 3, 6 and 12 months
DAN-PSS (Danish Prostate Symptom Score)
Time Frame: 0, 3, 6 and 12 months
symptom score
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
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
Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
IIEF (International Index of Erectile Function questionnaire)
Time Frame: 0,12 months
0,12 months
Prostate volume measured with TRUS (transrectal ultrasound)
Time Frame: 0, 12 moths
0, 12 moths
Rate of unscheduled hospital contacts
Time Frame: 12 months
12 months
IPSS (International Prostate Symptom Score)
Time Frame: 0, 3 and 6 months
0, 3 and 6 months

Collaborators and Investigators

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

Sponsor

University of Helsinki

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

September 1, 2011

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 26, 2014

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

  • 164/13/03/02/08

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.

Clinical Trials on BPH (Benign Prostatic Hyperplasia)

Clinical Trials on KTP Green Light Prostatectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe