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

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ClinicalTrials.gov Identifier: NCT00908427
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : May 25, 2009
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Procedure: photoselective vaporization prostatectomy (PVP) Procedure: Transurethral resection of the prostate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2004
Primary Completion Date : May 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. The changes of bladder outlet obstruction index (BOOI) [ Time Frame: 6months ]

Secondary Outcome Measures :
  1. The changes of Quality of Life (QoL) parameters [ Time Frame: 6, 12 months ]
  2. The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) [ Time Frame: 6, 12 months ]
  3. The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters [ Time Frame: 6months ]
  4. The changes of International Prostatic Symptom Scores (IPSS) [ Time Frame: 6, 12 months ]
  5. The changes of Schafer obstruction grade parameters [ Time Frame: 6months ]
  6. The changes of prostate volume [ Time Frame: 6, 12 months ]
  7. postoperative catheterization days [ Time Frame: immediate postoperative period ]
  8. Complications [ Time Frame: During all study periods ]
  9. The changes of the hemoglobin and the serum sodium and the serum PSA [ Time Frame: immediate postoperative period ]
  10. The change of IIEF score [ Time Frame: 6, 12 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sung Won Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00908427     History of Changes
Other Study ID Numbers: 2004-05-09
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms