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Completed

NCT Number: NCT02332538

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients' age ≥50 years
  • LUTS secondary to BOO due to BPH who failed medical treatment
  • International prostate symptom scores 8 (IPSS) >15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8)
  • 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.
  • ASA (American society of anaesthesiologists) score ≤3.
  • TRUS prostate size (>/=80ml)

Exclusion criteria

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection,
  • Presence of active bladder cancer (within the last 2 years)
  • 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.

Treatment and study plan

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

Procedure

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

Holmium laser enucleation of prostate

Procedure

Holmium-Yag laser enucleation of the prsotate

Bipolar TURP

Procedure

Bipolar transurethral resection of the prostate in saline

Primary outcomes

  1. Re treatment

    Time frame: 3 YEARs

    need for retreatment for recurrent infravesical obstruction following primary surgery

Secondary outcomes

  1. change in symptoms score

    Time frame: 3 year

    degree of improvement in the lower urinary tract symptoms

  2. Urine Flow rate (ml/sec)

    Time frame: 3 year

    degree of improvement in the rate of urine flow

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jan 7, 2015
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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