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

Mansoura University

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Benign Prostate Hyperplasia

Treatments: Procedure: Bipolar TURP; Procedure: Holmium laser enucleation of prostate; Procedure: 532nm-laser photoselective vapo-enucleation of the prostate)

Study type: Interventional

Funder types: Other

Identifiers

NCT02332538

MS/16.04.79

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 3 patient groups

Greenlight (532nm-laser) PVEP

Active Comparator group

Description:

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

Treatment:

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

Holmium laser enucleation of prostate

Active Comparator group

Description:

Holmium-Yag laser enucleation of the prostate

Treatment:

Procedure: Holmium laser enucleation of prostate

Bipolar TURP

Active Comparator group

Description:

Bipolar transurethral resection of the prostate in saline

Treatment:

Procedure: Bipolar TURP