Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

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)

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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