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

Primary Purpose

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
photoselective vaporization prostatectomy (PVP)
Transurethral resection of the prostate
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring benign prostatic hyperplasia, KTP laser, transurethral resection of prostate, urinary bladder neck obstruction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

PVP group

TURP group

Outcomes

Primary Outcome Measures

The changes of bladder outlet obstruction index (BOOI)

Secondary Outcome Measures

The changes of Quality of Life (QoL) parameters
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)
The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters
The changes of International Prostatic Symptom Scores (IPSS)
The changes of Schafer obstruction grade parameters
The changes of prostate volume
postoperative catheterization days
Complications
The changes of the hemoglobin and the serum sodium and the serum PSA
The change of IIEF score

Full Information

First Posted
May 22, 2009
Last Updated
May 22, 2009
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00908427
Brief Title
Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Keywords
benign prostatic hyperplasia, KTP laser, transurethral resection of prostate, urinary bladder neck obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
PVP group
Arm Title
2
Arm Type
Active Comparator
Arm Description
TURP group
Intervention Type
Procedure
Intervention Name(s)
photoselective vaporization prostatectomy (PVP)
Other Intervention Name(s)
PVP
Intervention Description
PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)
Intervention Type
Procedure
Intervention Name(s)
Transurethral resection of the prostate
Other Intervention Name(s)
TURP
Intervention Description
Standard transurethral resection of the prostate using electrocautery loop
Primary Outcome Measure Information:
Title
The changes of bladder outlet obstruction index (BOOI)
Time Frame
6months
Secondary Outcome Measure Information:
Title
The changes of Quality of Life (QoL) parameters
Time Frame
6, 12 months
Title
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)
Time Frame
6, 12 months
Title
The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters
Time Frame
6months
Title
The changes of International Prostatic Symptom Scores (IPSS)
Time Frame
6, 12 months
Title
The changes of Schafer obstruction grade parameters
Time Frame
6months
Title
The changes of prostate volume
Time Frame
6, 12 months
Title
postoperative catheterization days
Time Frame
immediate postoperative period
Title
Complications
Time Frame
During all study periods
Title
The changes of the hemoglobin and the serum sodium and the serum PSA
Time Frame
immediate postoperative period
Title
The change of IIEF score
Time Frame
6, 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Won Lee, Ph.D.,M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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