NCT00908427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
Last Updated

May 25, 2009

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

May 22, 2009

Last Update Submit

May 22, 2009

Conditions

Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasiaKTP lasertransurethral resection of prostateurinary bladder neck obstruction

Outcome Measures

Primary Outcomes (1)

  • The changes of bladder outlet obstruction index (BOOI)

    6months

Secondary Outcomes (10)

  • The changes of Quality of Life (QoL) parameters

    6, 12 months

  • The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)

    6, 12 months

  • The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters

    6months

  • The changes of International Prostatic Symptom Scores (IPSS)

    6, 12 months

  • The changes of Schafer obstruction grade parameters

    6months

  • +5 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

PVP group

Procedure: photoselective vaporization prostatectomy (PVP)

2

ACTIVE COMPARATOR

TURP group

Procedure: Transurethral resection of the prostate

Interventions

photoselective vaporization prostatectomy (PVP)PROCEDURE

PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)

Also known as: PVP
1
Transurethral resection of the prostatePROCEDURE

Standard transurethral resection of the prostate using electrocautery loop

Also known as: TURP
2

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsProstatic HyperplasiaUrinary Bladder Neck Obstruction

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sung-Won Lee, Ph.D.,M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 25, 2009

Study Start

June 1, 2004

Primary Completion

May 1, 2006

Study Completion

September 1, 2007

Last Updated

May 25, 2009

Record last verified: 2009-05

Locations

KR(1)