Actively Recruiting

Phase Not Applicable
Age: 45Years +
MALE
ID05678452

Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial

Led by Al-Azhar University · Updated on 2024-08-15

200

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two different power settings of Holmium laser enucleation of the prostate (HoLEP) in men with large prostates who require surgery due to benign prostatic hyperplasia. The study aims to evaluate the efficiency of low-power HoLEP against high-power HoLEP, focusing on benefits such as lower cost and fewer side effects like postoperative discomfort, urinary storage symptoms, and sexual impact. This is a prospective, randomized trial without masking. The treatments being compared are low-power HoLEP using a 2J/25Hz setting and high-power HoLEP using a 2J/50Hz setting, both performed with a 100W Versapulse laser device. Participants are randomly assigned to one of these two groups, and the procedures involve enucleation of the prostate tissue. This trial investigates which power setting is more efficient and has fewer complications. Participants will be monitored for enucleation efficiency measured within 3 hours of the procedure. Additional assessments include evaluating dysuria using a visual analog scale at 2 weeks and monitoring complications over 3 months. The study follows participants through these time points to understand treatment impact and safety. The total duration of involvement depends on these follow-up assessments.

CONDITIONS

Brief Title

Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

Who Can Participate

Age: 45Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Large prostate indicated for surgical intervention
Not Eligible

You will not qualify if you...

  • Prostate cancer
  • Recurrent adenomas
  • Associated neurologic factors that may affect outcomes such as neurogenic bladder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 3 hours

Participants undergo prostate enucleation using high or low power HOLEP settings and receive immediate care following surgery.

1 surgical procedure visit (in-person)

Post-operative Follow-up

Duration - Up to 3 months

Participants are assessed for dysuria and monitored for complications following the surgery.

Multiple follow-up visits up to 3 months

Trial Site Locations

Total: 1 location

1

Urology department - AlAzhar university

Cairo, Egypt

Actively Recruiting

Loading map...

Research Team

M

Mohamed F Salman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therap...

Benign Prostatic Hyperplasia

Actively Recruiting

1 location

A Clinical Observation Study of a Chinese Patent Medicine Co...

Benign Prostatic Hyperplasia

Actively Recruiting

1 location

A Prospective, Multicenter, Double Blind, Randomized Clinica...

Benign Prostatic Hyperplasia

Actively Recruiting

20 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here