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

Mansoura University

Status and phase: Unknown; Phase 4

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Greenlight laser PVP; Procedure: HoLEP

Study type: Interventional

Funder types: Other

Identifiers

NCT02293759

Mans-2014-04

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

HoLEP

Active Comparator group

Description:

Holmium laser enucleation of the prostate

Treatment:

Procedure: HoLEP

Greenlight laser PVP

Active Comparator group

Description:

Phtoselective vaporization of the prostate

Treatment:

Procedure: Greenlight laser PVP