Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency

Phase 4

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: HoLEP; Procedure: Greenlight laser PVP

• Registration Number: NCT02293759
• Lead Sponsor: Mansoura University

Brief Summary

Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.

Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP

Detailed Description

Elderly patients with bleeding tendency either secondary;

1. Strict antiplatelet intake

2. Strict anticoagulant intake

3. uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.

Laser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-27
• Last Update Posted: 2016-03-29
• Primary Completion: 2016-08
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• BPH patients candidate for transurethral prostate surgery after failure of medical treatment

• Perioperative uncorrected Blleding tendency

  1. patients with naturally induced uncorrectable bleeding tendency;

     1. platelet count less than 100000/mm3
     2. INR more than 1.5

  2. Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist

  3. Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist

Exclusion Criteria

• Correctable bleeding tendency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HoLEP	HoLEP	Holmium laser enucleation of the prostate
Greenlight laser PVP	Greenlight laser PVP	Phtoselective vaporization of the prostate

Primary Outcome Measures

Name	Time	Method
perioperative blood loss	48 hours

Secondary Outcome Measures

Name	Time	Method
flow rate	3 months
readmission	30 days
blood transfusion	30 days

Trial Locations

Locations (1)

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