Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00877669

Enrollment

313

Registered

2009-04-08

Start date

2008-10-31

Completion date

2016-12-31

Last updated

2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

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).

Interventions

PROCEDURETransurethral resection of the prostate

Standard transurethral resection of the prostate using electrocautery loop

PROCEDUREHolmium Laser Enucleation of the Prostate

HoLEP using 100W Ho:YAG laser

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026