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

Lower Urinary Tract Symptoms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332538
• Other study ID #: MS/16.04.79
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 2019

Study information

• Verified date: October 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 2019
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Procedure:
• 532nm-laser photoselective vapo-enucleation of the prostate)
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 prsotate
• Bipolar TURP
Bipolar transurethral resection of the prostate in saline

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re treatment	need for retreatment for recurrent infravesical obstruction following primary surgery	3 YEARs
Secondary	change in symptoms score	degree of improvement in the lower urinary tract symptoms	3 year
Secondary	Urine Flow rate (ml/sec)	degree of improvement in the rate of urine flow	3 year