Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia

May 22, 2009 updated by: Samsung Medical Center

Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial

The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

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

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Symptomatic BPH
  • International Score Prostate Symptom (IPSS) of 13 or greater
  • prostate volume of 30 to 100 ML
  • Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL
  • Able to give fully informed consent

Exclusion Criteria:

  • Subjects with histological diagnosis of prostate cancer
  • Subjects with history of chronic urinary retention
  • Subjects with urethral stricture,
  • Subjects with bladder neck contracture
  • Subjects with urinary tract infection
  • Subjects with prostate volume on TRUS of >100 mL
  • Subjects with suspected neurogenic bladder dysfunction
  • Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
PVP group
Procedure: photoselective vaporization prostatectomy (PVP)
PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)
Other Names:
  • PVP
Active Comparator: 2
TURP group
Procedure: Transurethral resection of the prostate
Standard transurethral resection of the prostate using electrocautery loop
Other Names:
  • TURP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The changes of bladder outlet obstruction index (BOOI)
Time Frame: 6months
6months

Secondary Outcome Measures

Outcome Measure
Time Frame
The changes of Quality of Life (QoL) parameters
Time Frame: 6, 12 months
6, 12 months
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)
Time Frame: 6, 12 months
6, 12 months
The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters
Time Frame: 6months
6months
The changes of International Prostatic Symptom Scores (IPSS)
Time Frame: 6, 12 months
6, 12 months
The changes of Schafer obstruction grade parameters
Time Frame: 6months
6months
The changes of prostate volume
Time Frame: 6, 12 months
6, 12 months
postoperative catheterization days
Time Frame: immediate postoperative period
immediate postoperative period
Complications
Time Frame: During all study periods
During all study periods
The changes of the hemoglobin and the serum sodium and the serum PSA
Time Frame: immediate postoperative period
immediate postoperative period
The change of IIEF score
Time Frame: 6, 12 months
6, 12 months

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Sung-Won Lee, Ph.D.,M.D., Samsung Medical Center

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

June 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Estimate)

May 25, 2009

Last Update Submitted That Met QC Criteria

May 22, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-05-09

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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