Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

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Samsung Medical Center

Status and phase

Completed
Phase 2

Conditions

Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia

Treatments

Procedure: Holmium Laser Enucleation of the Prostate
Procedure: Transurethral resection of the prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT00877669
2008-10-038

Details and patient eligibility

About

The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).

Enrollment

313 patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 50 yrs or greater
  • International prostatic symptom score >= 12
  • Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
  • Able to give fully informed consent

Exclusion criteria

  • Patients with urologic malignancies such as prostate cancer and bladder cancer
  • Patients underwent urethral, prostate surgery
  • Patients with urethral stricture or bladder diverticulum or bladder neck contracture
  • Patients with histories of bacterial prostatitis within 1 year
  • seems not to be appropriate to this study by the decision of investigators because of any other reasons

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

313 participants in 2 patient groups

Transurethral resection of the prostate
Active Comparator group
Description:
TURP group
Treatment:
Procedure: Transurethral resection of the prostate
Holmium Laser Enucleation of Prostate
Experimental group
Description:
HoLEP group
Treatment:
Procedure: Holmium Laser Enucleation of the Prostate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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