Clinical trial NCT02283684: GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
Official title: Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: LASER
PROSTATE
BIPOLAR
HYPERPLASIA
VAPORIZATION
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 120
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: With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/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 PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.

Detailed description: Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.

Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.

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 (IPSS) \>15 and bother score (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 (from 30 to 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: IPSS change
timeFrame: two years
Secondary outcomes:
measure: Reoperation rate
timeFrame: 4 years
measure: Q.max
timeFrame: 2 years
measure: biopsy
timeFrame: one month
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: