Clinical trial NCT02332538: HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH
Official title: Randomized Trial Comparing Holmium Laser Enucleation of the Prostate vs. Greenlight 532nm-laser Vapo-Enucleation of the Prostate vs. Bipolar Transurethral Resection of the Prostate in Management of Moderate/Large Benign Prostate Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostate Hyperplasia
Lower Urinary Tract Symptoms
Keywords: LASER
PROSTATE
BIPOLAR
HYPERPLASIA
VAPORIZATION
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 182
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Re treatment
timeFrame: 3 YEARs
Secondary outcomes:
measure: change in symptoms score
timeFrame: 3 year
measure: Urine Flow rate (ml/sec)
timeFrame: 3 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed M Elshal, MD
role: PRINCIPAL_INVESTIGATOR
References: