Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00908427
First received: May 22, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
 Procedure: photoselective vaporization prostatectomy (PVP)
Procedure: Transurethral resection of the prostate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The changes of bladder outlet obstruction index (BOOI) [ Time Frame: 6months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The changes of Quality of Life (QoL) parameters [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • The changes of International Prostatic Symptom Scores (IPSS) [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • The changes of Schafer obstruction grade parameters [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • The changes of prostate volume [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • postoperative catheterization days [ Time Frame: immediate postoperative period ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: During all study periods ] [ Designated as safety issue: Yes ]
  • The changes of the hemoglobin and the serum sodium and the serum PSA [ Time Frame: immediate postoperative period ] [ Designated as safety issue: Yes ]
  • The change of IIEF score [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: June 2004
Study Completion Date: September 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PVP
Active Comparator: 2
TURP group
 Procedure: Transurethral resection of the prostate
Standard transurethral resection of the prostate using electrocautery loop
Other Name: TURP

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908427

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sung-Won Lee, Ph.D.,M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Sung Won Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00908427     History of Changes
Other Study ID Numbers: 2004-05-09
Study First Received: May 22, 2009
Last Updated: May 22, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
benign prostatic hyperplasia
KTP laser
transurethral resection of prostate
urinary bladder neck obstruction

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013