UI Health SCB Clinic Department of Urology
Chicago, Illinois, 60612, United States
Location status: Recruiting
NCT Number: NCT06224218
Surgical treatments for benign prostatic hyperplasia (BPH) are necessary when non-procedural approaches fail to alleviate lower urinary tract symptoms (LUTS) or bladder outlet obstruction (BOO). Open simple prostatectomy and laser enucleation are recommended for prostatic adenoma size greater than 80 ml. Minimally invasive approaches, such as robotic-assisted simple prostatectomy, have gained popularity due to their comparable outcomes with lower morbidity. The introduction of the da Vinci single-port (SP) robotic platform offers potential advantages, but its outcomes have not been thoroughly investigated.
This randomized controlled trial aims to compare the outcomes of SP simple prostatectomy performed using the da Vinci robotic platform versus thulium laser enucleation of the prostate for the treatment of BPH and BOO.
Interested in participating?
Request Info18 year–88 year
Male
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Location status: Recruiting
Patients diagnosed with symptomatic BPH and eligible for surgical intervention will be randomized to undergo either SP robotic simple prostatectomy or thulium laser enucleation of the prostate. Primary outcomes will include perioperative parameters (operative time, estimated blood loss, hospital stay), postoperative complications, and functional outcomes (urinary symptoms, urinary flow rate). Secondary outcomes will evaluate perioperative and postoperative complications, oncologic outcomes, and patient-reported quality of life measures.
In a recent retrospective study at UI Health from 2017 to 2021, investigators compared 103 procedures, SP robotic prostatectomy versus laser enucleation, 34 SP robotic prostatectomy and 69 laser enucleations. There was no difference in any complication at 30-day post-surgery (21.2% vs. 21.7%, p=0.9517). Investigators recognize SP robotic surgery leads to longer operating times, due to docking the instrument and closing the incision, as well as longer catheter times to allow the cystostomy to heal. While the laser enucleation may be considered less invasive, as no incision is required, the instrumentation of the urethra could lead to urethral strictures. This study aims to provide valuable insights into the clinical outcomes of single port simple prostatectomy using SP robotic platform, compared to laser enucleation of the prostate prospectively. The results of this trial will help guide clinicians and patients in selecting the most appropriate surgical intervention for symptomatic BPH, considering both functional outcomes and morbidity. Both procedures are currently performed at UI Health, they are FDA approved, therefore this is not a safety study. Subject insurance will not impact which subject will receive one procedure or the other, as both procedures are recommended on the American Urological Association guidelines for Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia.
The study will be a randomized controlled trial comparing SP simple prostatectomy vs laser enucleation of the prostate. The study findings will improve clinical decision-making and aid in optimizing patient outcomes in the management of BPH.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single port Robotic surgery will remove the whole prostate
Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.
Time frame: During procedure
Time in minutes from the start to finish of the procedure.
Time frame: Before procedure and 7 months after procedure
How often do you leak urine? never 0 about once a week 1 two or three times a week 2 about once a day 3 several times a day 4 all the time 5
How much urine do you usually leak (whether you wear protection or not)? none 0 a small amount 2 a moderate amount 4 a large amount 6
Overall, how much does leaking urine interfere with your everyday life? 0 (not at all) and 10 (a great deal) 0 1 2 3 4 5 6 7 8 9 10
ICIQ score: sum previous questions.
When does urine leak? never - urine does not leak before you can get to the toilet when you cough or sneeze when you are asleep when you are physically active/exercising when you have finished urinating and are dressed for no obvious reason all the time
Time frame: Before procedure and 7 months after procedure
Add together the numbers. If the patient's score is 21 or less, erectile dysfunction (ED) should be addressed.
22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction
Time frame: Before procedure and 7 months after procedure
0= not all
0 1 2 3 4 5
0 1 2 3 4 5
0 1 2 3 4 5
0 1 2 3 4 5
0 1 2 3 4 5
0 1 2 3 4 5
Sum previous questions to have the score:
0 - 7 = mildly symptomatic; 8 - 19 = moderately 20 - 35 = severely
Time frame: Before procedure and 7 months after procedure
Measure of the urine flow in mL/s
Time frame: Before procedure and 7 months after procedure
Amount of urine retained in the bladder after a voluntary void measure with Ultrasound.
Volume = length x width x height x 0.52
Time frame: During procedure
Estimate blood loss in mL during procedure
Time frame: From end of procedure to discharge home (up to 30 days )
Amount of time spent at the hospital after procedure measure in hours
Time frame: During procedure
Descriptive report of complications during surgery.
Time frame: Before procedure and 7 months after procedure
If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?
0 1 2 3 4 5 6
0= delighted
Time frame: 2 weeks after procedure
Pathology report of prostate tissue, presence or absence of prostate cancer.
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
Randomized Controlled Trial Comparing Single Port Simple Prostatectomy and Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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