Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
MALE
NCT03305861

Green LEP vs ThuLEP in Management of Marked Enlarged Prostate

Led by Mansoura University · Updated on 2024-10-30

110

Participants Needed

1

Research Sites

395 weeks

Total Duration

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AI-Summary

What this Trial Is About

In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures will be compared.

CONDITIONS

Official Title

Green LEP vs ThuLEP in Management of Marked Enlarged Prostate

Who Can Participate

Age: 40Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 40 years or older
  • Lower urinary tract symptoms due to bladder outlet obstruction from benign prostatic hyperplasia that did not improve with medical treatment
  • International prostate symptom scores (IPSS) greater than 15 and quality of life bother score of 3 or more
  • Peak urinary flow rate less than 15 ml/sec with at least 125 ml voided volume, or acute urine retention secondary to BPH that failed medical treatment
  • American Society of Anesthesiologists (ASA) score of 3 or less
  • Prostate size 80 ml or larger as measured by transrectal ultrasound (TRUS)
Not Eligible

You will not qualify if you...

  • Neurological disorders affecting bladder function, such as stroke or Parkinson's disease
  • Active urinary tract infection
  • Active bladder cancer within the last 2 years
  • Known prostate cancer based on examination, PSA levels, imaging, or biopsy
  • Blood clotting disorders or platelet function disorders that increase bleeding risk
  • Unable to stop anticoagulant or antiplatelet therapy before surgery (except low-dose aspirin)
  • Recent acute myocardial infarction or open-heart surgery within 180 days prior to consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, Egypt

Actively Recruiting

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Research Team

M

Mahmoud Nabil Laymon, MD

CONTACT

A

Adel M Nabeeh, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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