HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH

Not Applicable

Completed

• Conditions: Benign Prostate Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Procedure: 532nm-laser photoselective vapo-enucleation of the prostate); Procedure: Holmium laser enucleation of prostate; Procedure: Bipolar TURP

• Registration Number: NCT02332538
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-12-27
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Primary Completion: 2016-07
• Study Completion: 2019-07
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-13
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Greenlight (532nm-laser) PVEP	532nm-laser photoselective vapo-enucleation of the prostate)	532nm-laser photoselective vapo-enucleation of the prostate)
Holmium laser enucleation of prostate	Holmium laser enucleation of prostate	Holmium-Yag laser enucleation of the prostate
Bipolar TURP	Bipolar TURP	Bipolar transurethral resection of the prostate in saline

Primary Outcome Measures

Name	Time	Method
Re treatment	3 YEARs	need for retreatment for recurrent infravesical obstruction following primary surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt