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

NCT ID: NCT02332538

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-07-31

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.

Conditions

Benign Prostate Hyperplasia; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Greenlight (532nm-laser) PVEP

532nm-laser photoselective vapo-enucleation of the prostate)

Group Type: ACTIVE_COMPARATOR

532nm-laser photoselective vapo-enucleation of the prostate)

Intervention Type: PROCEDURE

using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)

Holmium laser enucleation of prostate

Holmium-Yag laser enucleation of the prostate

Group Type: ACTIVE_COMPARATOR

Holmium laser enucleation of prostate

Intervention Type: PROCEDURE

Holmium-Yag laser enucleation of the prsotate

Bipolar TURP

Bipolar transurethral resection of the prostate in saline

Group Type: ACTIVE_COMPARATOR

Bipolar TURP

Intervention Type: PROCEDURE

Bipolar transurethral resection of the prostate in saline

Interventions

532nm-laser photoselective vapo-enucleation of the prostate)

using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)

Intervention Type: PROCEDURE

Holmium laser enucleation of prostate

Holmium-Yag laser enucleation of the prsotate

Intervention Type: PROCEDURE

Bipolar TURP

Bipolar transurethral resection of the prostate in saline

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elshal

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Elshal, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

Other Identifiers

MS/16.04.79

Identifier Type: -

Identifier Source: org_study_id