Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Conditions
Keywords
benign prostatic hyperplasia, KTP laser, transurethral resection of prostate, urinary bladder neck obstruction
Brief summary
The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.
Interventions
PROCEDUREphotoselective vaporization prostatectomy (PVP)
PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)
Standard transurethral resection of the prostate using electrocautery loop
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic BPH * International Score Prostate Symptom (IPSS) of 13 or greater * prostate volume of 30 to 100 ML * Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of \>125 mL and a PVR \<350mL * Able to give fully informed consent
Exclusion criteria
* Subjects with histological diagnosis of prostate cancer * Subjects with history of chronic urinary retention * Subjects with urethral stricture, * Subjects with bladder neck contracture * Subjects with urinary tract infection * Subjects with prostate volume on TRUS of \>100 mL * Subjects with suspected neurogenic bladder dysfunction * Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of bladder outlet obstruction index (BOOI) | 6months |
Secondary
| Measure | Time frame |
|---|---|
| The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) | 6, 12 months |
| The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters | 6months |
| The changes of International Prostatic Symptom Scores (IPSS) | 6, 12 months |
| The changes of Schafer obstruction grade parameters | 6months |
| The changes of Quality of Life (QoL) parameters | 6, 12 months |
| postoperative catheterization days | immediate postoperative period |
| Complications | During all study periods |
| The changes of the hemoglobin and the serum sodium and the serum PSA | immediate postoperative period |
| The change of IIEF score | 6, 12 months |
| The changes of prostate volume | 6, 12 months |
Countries
South Korea
Outcome results
None listed