Surgical treatment of benign prostatic hyperplasia: Thulium enucleation versus single-port transvesical robotic simple prostatectomy.
Susan Talamini, Andrew Lai, Cassandra Palmer...
https://pubmed.ncbi.nlm.nih.gov/37636211Actively Recruiting
Led by University of Illinois at Chicago · Updated on 2024-05-16
116
Participants Needed
1
Research Sites
30 weeks
Total Duration
This research aims to compare two surgical treatments for benign prostatic hyperplasia (BPH) in men who experience lower urinary tract symptoms or bladder outlet obstruction after non-surgical treatments have not worked. The trial evaluates the outcomes of a newer single port robotic simple prostatectomy using the da Vinci platform against thulium laser enucleation of the prostate. Both procedures are recommended for larger prostate sizes and are performed to address urinary symptoms related to BPH. Participants will be randomly assigned to receive either the single port robotic prostatectomy, which removes the whole prostate through a small incision using robotic assistance, or laser enucleation, which removes prostate tissue using laser technology while preserving the prostate capsule. This study will measure surgical parameters like operative time, blood loss, and hospital stay, as well as post-surgical complications and urinary function outcomes. The trial also assesses quality of life and sexual health before and seven months after surgery. During the study, participants will undergo evaluations including questionnaires about urinary symptoms, sexual health, and quality of life, as well as tests measuring urinary flow rate and residual urine volume. Researchers will track surgical complications and any incidental findings of cancer. The trial's findings aim to help guide patients and doctors in choosing the best surgical option for BPH. The total participation duration includes assessments before and seven months after the procedure, with monitoring during and immediately after surgery.
CONDITIONS
Prostate Single Port & Laser Enucleation Comparison Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 days from surgery to discharge
Participants undergo either single port robotic simple prostatectomy or laser enucleation of the prostate for treatment of benign prostatic hyperplasia. Perioperative parameters such as operative time, blood loss, and hospital stay are monitored.
1 surgery visit and hospital stay up to 30 days
Duration - 7 months after surgery
Participants are assessed for functional outcomes including urinary symptoms, urinary flow rate, sexual health, and quality of life. Additional monitoring for incidental cancer occurs 2 weeks after surgery.
Visits before surgery, at 2 weeks post-surgery, and follow-up visits up to 7 months
Total: 1 location
1
UI Health SCB Clinic Department of Urology
Chicago, Illinois, United States, 60612
Actively Recruiting
R
Ruben Sauer, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Susan Talamini, Andrew Lai, Cassandra Palmer...
https://pubmed.ncbi.nlm.nih.gov/37636211Alfredo Maria Bove, Aldo Brassetti, Mario Ochoa...
https://pubmed.ncbi.nlm.nih.gov/37483855