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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prospective Non-randomized Trial Comparing Holmium Laser Enucleation of the Prostate Versus Greenlight Laser Photoselective Vaporization of the Prostate in Treating Benign Prostate Hyperplasia in Patients With Bleeding Tendency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02293759
• Other study ID #: Mans-2014-04
• Status: Recruiting
• Phase: Phase 4
• First received: November 13, 2014
• Last updated: March 27, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Mansoura University
• Contact: Ahmed m Elshal, MD
• Phone: +20502262222
• Email: ELSHALAM[@]GMAIL.COM
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Blood Coagulation Disorders
• Hemostatic Disorders
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• HoLEP
Holmium laser enucleation of the prsotate
• Greenlight laser PVP
Greenlight laser (532nm) Photoslective vaporization of the prostate

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	perioperative blood loss		48 hours	Yes
Secondary	readmission		30 days	Yes
Secondary	blood transfusion		30 days	Yes
Secondary	flow rate		3 months	No