Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Large prostate indicated for surgical intervention
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
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
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