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Procedure
Robotic vs Laser Surgery for Enlarged Prostate
N/A
Recruiting
Led By Simone Crivellaro, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Adults unable to consent
Cognitive impaired adults
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after procedure
Awards & highlights
Summary
"This trial aims to compare the outcomes of using a new robotic platform for prostate surgery with the current standard laser treatment for patients with enlarged prostates. The goal is to see which treatment is more effective for
Who is the study for?
Men with symptomatic Benign Prostatic Hyperplasia (BPH) not relieved by medication are eligible for this trial. It's not open to those who can't consent, prisoners, adults with cognitive impairments, or individuals with coagulopathy (a condition affecting blood clotting).
What is being tested?
The trial is comparing two surgical approaches for BPH: a new robotic-assisted surgery using the da Vinci single-port platform and traditional thulium laser enucleation. Participants will be randomly assigned to one of these treatments.
What are the potential side effects?
Potential side effects may include typical surgical risks such as bleeding, infection, pain at the incision site, urinary issues, and possibly sexual dysfunction. The exact side effects depend on the individual's response to surgery.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to give consent for medical procedures.
Select...
I have a cognitive impairment.
Select...
I have a blood clotting disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks after procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood loss during procedure
Hospital stay after procedure
International Consultation of Incontinence Questionnaire Short Form
+5 moreSecondary outcome measures
Number of subjects with incidental cancer
Number of subjects with injuries related to surgical procedures.
Quality of life due to urinary symptoms
Trial Design
2Treatment groups
Active Control
Group I: Single Port Robotic ProstatectomyActive Control1 Intervention
Removal of the prostate using single port robot
Group II: Laser Enucleation of the ProstateActive Control1 Intervention
Enucleation of the prostate with laser surgery
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
632 Previous Clinical Trials
1,567,599 Total Patients Enrolled
Simone Crivellaro, MDPrincipal InvestigatorUniversity of Illinois at Chicago, Department of Urology
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