Prostate Single Port & Laser Enucleation Comparison Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Hyperplasia
• Intervention / Treatment: Procedure: Single Port Robotic Surgery; Procedure: Laser Surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruben Sauer, MD; Phone Number: 3124135288; Email: rsauer1@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • UI Health SCB Clinic Department of Urology
      • Contact: Ruben Sauer, MD; Phone Number: 312-413-5288; Email: rsauer1@uic.edu
      • Principal Investigator: Simone Crivellaro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who fail conservative treatment with drug therapy are eligible for surgical intervention.

Exclusion Criteria:

• Adults unable to consent Prisoners Cognitive impaired adults Coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single Port Robotic Prostatectomy; Removal of the prostate using single port robot	Procedure: Single Port Robotic Surgery; Single port Robotic surgery will remove the whole prostate
Active Comparator: Laser Enucleation of the Prostate; Enucleation of the prostate with laser surgery	Procedure: Laser Surgery; Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Time in minutes from the start to finish of the procedure.	During procedure
International Consultation of Incontinence Questionnaire Short Form	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	Before procedure and 7 months after procedure
Sexual Health Inventory for Men (SHIM)	How do you rate your confidence to keep an erection? 1 Very low 2 3 4 5 Very high; How often were your erections hard enough for penetration? 1 Almost never 2 3 4 5Almost always; How often were you able to maintain your erection after you had penetrated your partner? 1Almost never 2 3 4 5Almost always; How difficult was it to maintain your erection to completion of intercourse? 1Extremely difficult 2 3 4 5Not difficult; When you attempted sexual intercourse, how often was it satisfactory for you? 1Almost never 2 3 4 5Almost always 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	Before procedure and 7 months after procedure
International Prostate Symptom Score I-PSS	1. How often have you had a sensation of not emptying your bladder completely after you finish urinating? 0= not all; less than 1 time in 5; less than half the time; about half the time; more than half the time; almost always 2. How often have you had to urinate again less than two hours after you have finished urinating? 0 1 2 3 4 5 3. How often have you found you stopped and started again several times when you urinated? 0 1 2 3 4 5 4. How often have you found it difficult to postpone urination? 0 1 2 3 4 5 5. How often have you had a weak urinary stream? 0 1 2 3 4 5 6. How often have you had to push or strain to begin urination? 0 1 2 3 4 5 7. How many times did you most typically get up each night to urinate from the time you went to bed until the time you got up in the morning? 0 1 2 3 4 5 Sum previous questions to have the score: 0 - 7 = mildly symptomatic; 8 - 19 = moderately 20 - 35 = severely	Before procedure and 7 months after procedure
Urinary flow rate	Measure of the urine flow in mL/s	Before procedure and 7 months after procedure
Post void residual volume	Amount of urine retained in the bladder after a voluntary void measure with Ultrasound. Volume = length x width x height x 0.52	Before procedure and 7 months after procedure
Blood loss during procedure	Estimate blood loss in mL during procedure	During procedure
Hospital stay after procedure	Amount of time spent at the hospital after procedure measure in hours	From end of procedure to discharge home (up to 30 days )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with injuries related to surgical procedures.	Descriptive report of complications during surgery.	During procedure
Quality of life due to urinary symptoms	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; please; mostly satisfied; mixed; mostly unhappy; unhappy; terrible	Before procedure and 7 months after procedure
Number of subjects with incidental cancer	Pathology report of prostate tissue, presence or absence of prostate cancer.	2 weeks after procedure

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Simone Crivellaro, MD, University of Illinois at Chicago, Department of Urology

Publications and helpful links

General Publications

• Talamini S, Lai A, Palmer C, van de Walle G, Zuberek M, Crivellaro S. Surgical treatment of benign prostatic hyperplasia: Thulium enucleation versus single-port transvesical robotic simple prostatectomy. BJUI Compass. 2023 Jun 22;4(5):549-555. doi: 10.1002/bco2.261. eCollection 2023 Sep.
• Bove AM, Brassetti A, Ochoa M, Anceschi U, D'Annunzio S, Ferriero M, Tuderti G, Misuraca L, Mastroianni R, Cartolano S, Torregiani G, Lombardo R, De Nunzio C, Simone G. Robotic simple prostatectomy vs HOLEP, a 'multi single-center' experiences comparison. Cent European J Urol. 2023;76(2):128-134. doi: 10.5173/ceju.2023.204. Epub 2023 Apr 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: Study 2023-1335

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No