Actively Recruiting

Phase Not Applicable
Age: 18Years - 88Years
MALE
ID06224218

Randomized Controlled Trial Comparing Single Port Simple Prostatectomy and Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia

Led by University of Illinois at Chicago · Updated on 2024-05-16

116

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Prostate Single Port & Laser Enucleation Comparison Trial

Who Can Participate

Age: 18Years - 88Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who fail conservative treatment with drug therapy are eligible for surgical intervention.
Not Eligible

You will not qualify if you...

  • Adults unable to consent
  • Prisoners
  • Cognitive impaired adults
  • Coagulopathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 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

Post-operative Follow-up

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

Trial Site Locations

Total: 1 location

1

UI Health SCB Clinic Department of Urology

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

R

Ruben Sauer, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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/37636211