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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02293759

Enrollment

Registered

2014-11-18

Start date

2014-10-31

Completion date

2016-09-30

Last updated

2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH- LASER- PROSTATE- BLEEDING TENDENCY

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

Interventions

PROCEDUREHoLEP

Holmium laser enucleation of the prsotate

PROCEDUREGreenlight laser PVP

Greenlight laser (532nm) Photoslective vaporization of the prostate

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
perioperative blood loss	48 hours

Secondary

Measure	Time frame
readmission	30 days
blood transfusion	30 days
flow rate	3 months

Countries

Egypt

Contacts

Primary ContactAhmed m Elshal, MD

ELSHALAM@GMAIL.COM+20502262222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026