Clinical trial NCT00877669: Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 313
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
timeFrame: 6 months
Secondary outcomes:
measure: The changes of Quality of Life (QoL) parameters
timeFrame: 6 months
measure: The changes of IPSS and QoL parameters
timeFrame: 1 month and 3months after operation
measure: The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters
timeFrame: 2 weeks and 3 and 6 months after operation
measure: Postoperative hospital stay days and postoperative catheterization days
timeFrame: immediate postoperative period
measure: The changes of the hemoglobin and the serum sodium
timeFrame: 0 and 1 day after operation
measure: Operative time and Resected tissue weight
timeFrame: 0 day after operation
measure: The changes of ICS male questionnaire (short form) parameters
timeFrame: 3 and 6 months after operation
measure: The changes of international index of erectile function (IIEF)-15 parameters
timeFrame: 6 months after operation
measure: The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters
timeFrame: 3 and 6 months after operation
measure: The changes of voiding frequencies and urgency parameters in Frequency volume chart
timeFrame: 3 and 6 months after operation
measure: Ejaculation parameter
timeFrame: 6 months after operation
measure: Complications
timeFrame: During all study periods
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References: