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

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Samsung Medical Center

Status

Completed

Conditions

Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia

Treatments

Procedure: photoselective vaporization prostatectomy (PVP)
Procedure: Transurethral resection of the prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT00908427
2004-05-09

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

Male

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

1
Active Comparator group
Description:
PVP group
Treatment:
Procedure: photoselective vaporization prostatectomy (PVP)
2
Active Comparator group
Description:
TURP group
Treatment:
Procedure: Transurethral resection of the prostate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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