Benign Prostate Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
Brief summary
Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate. In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.
Detailed description
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology. In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of LUTS secondary to BPH in a prospective randomized trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. The prostate size limitations will be assessed in relation to the outcome measures. Moderate to large size prostate (80-120 ml TRUS estimated volume) will be randomized to PVEP vs. Bipolar TURP vs. HoLEP.
Interventions
PROCEDURE532nm-laser photoselective vapo-enucleation of the prostate)
using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)
Holmium-Yag laser enucleation of the prsotate
PROCEDUREBipolar TURP
Bipolar transurethral resection of the prostate in saline
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients' age ≥50 years 2. LUTS secondary to BOO due to BPH who failed medical treatment 3. International prostate symptom scores 8 (IPSS) \>15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8) 4. Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment. 5. ASA (American society of anaesthesiologists) score ≤3. 6. TRUS prostate size (\>/=80ml)
Exclusion criteria
1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease 2. Active urinary tract infection, 3. Presence of active bladder cancer (within the last 2 years) 4. Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re treatment | 3 YEARs | need for retreatment for recurrent infravesical obstruction following primary surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in symptoms score | 3 year | degree of improvement in the lower urinary tract symptoms |
| Urine Flow rate (ml/sec) | 3 year | degree of improvement in the rate of urine flow |
Countries
Egypt
Outcome results
None listed