The Comparison of Efficacy 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)

Samsung Medical Center1 site in 1 country313 target enrollmentOctober 2008

ConditionsLower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lower Urinary Tract Symptoms
Sponsor: Samsung Medical Center
Enrollment: 313
Locations: 1
Primary Endpoint: The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

December 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

KYU-SUNG LEE

Urology, Professor

Samsung Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation

Time Frame: 6 months

Secondary Outcomes

Ejaculation parameter(6 months after operation)
The changes of the hemoglobin and the serum sodium(0 and 1 day after operation)
Postoperative hospital stay days and postoperative catheterization days(immediate postoperative period)
Complications(During all study periods)
The changes of IPSS and QoL parameters(1 month and 3months after operation)
Operative time and Resected tissue weight(0 day after operation)
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters(3 and 6 months after operation)
The changes of Quality of Life (QoL) parameters(6 months)
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters(2 weeks and 3 and 6 months after operation)
The changes of voiding frequencies and urgency parameters in Frequency volume chart(3 and 6 months after operation)
The changes of ICS male questionnaire (short form) parameters(3 and 6 months after operation)
The changes of international index of erectile function (IIEF)-15 parameters(6 months after operation)