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HoLEP for Prostate Obstruction
N/A
Recruiting
Led By Amy Krambeck, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males aged 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms typically caused by enlarged prostates
Be older than 18 years old
Must not have
Patients lacking decisional capacity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the effect of different laser settings (frequency and wattage) during a prostate surgery procedure. The researchers do not have a standard laser setting for this procedure yet. They want to
Who is the study for?
This trial is for individuals with prostate obstruction or urological diseases who are candidates for HoLEP, a laser treatment to remove prostate tissue. Specific eligibility criteria aren't provided, but typically participants would need to be suitable for the procedure.
What is being tested?
The study tests different laser settings during HoLEP procedures to find out if higher or lower settings affect the surgery time and postoperative outcomes like irritative voiding symptoms without causing harm.
What are the potential side effects?
While specific side effects of varying laser settings in HoLEP are not detailed, common ones may include discomfort, urinary issues, bleeding, infection risk post-surgery, and potential impacts on sexual function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18-89 getting HoLEP for urinary issues due to an enlarged prostate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to make my own medical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: 2J 60hz Laser EnergyExperimental Treatment1 Intervention
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz
Group II: 2J 50hz Laser EnergyExperimental Treatment1 Intervention
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz
Group III: 2J 40hz Laser EnergyExperimental Treatment1 Intervention
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,642 Previous Clinical Trials
957,772 Total Patients Enrolled
Amy Krambeck, MDPrincipal InvestigatorNorthwestern
3 Previous Clinical Trials
398 Total Patients Enrolled
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