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

March 5, 2024 updated by: Hannu Koistinen, University of Helsinki

The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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, 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men with anticoagulant medication 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
Experimental: KTP laser
device
Procedure: KTP laser
Other Names:
  • Green laser
Active Comparator: TUR-P
device
Procedure: TUR-P
device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Re-bleeding rate requiring hospitalization
Time Frame: two months postoperatively
two months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative bleeding
Time Frame: Time of operation
Time of operation
IPSS (International Prostate Symptom Score)
Time Frame: 0, 3, 6 and 12 months
symptom score
0, 3, 6 and 12 months
DAN-PSS (Danish Prostate Symptom Score)
Time Frame: 0, 3, 6 and 12 months
0, 3, 6 and 12 months
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
Length of catheterization
Time Frame: Participants will be followed for the duration of hospital stay, an expected maximum of one week
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
Participants will be followed for the duration of hospital stay, an expected maximum of one week
IIEF (International Index of Erectile Function) questionnaire
Time Frame: 0,12 months
0,12 months
TRUS (transrectal ultrasound)
Time Frame: 0, 12 months
0, 12 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

March 1, 2011

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimated)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35/13/03/02/08

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 laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe