Prostate Single Port & Laser Enucleation Comparison Trial

Official title

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

Overview

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.

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.

Interventions

• Procedure Single Port Robotic Surgery
  Single port Robotic surgery will remove the whole prostate
• Procedure Laser Surgery
  Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.

Primary outcome measures

• Operative time [Time frame: During procedure]
• International Consultation of Incontinence Questionnaire Short Form [Time frame: Before procedure and 7 months after procedure]
• Sexual Health Inventory for Men (SHIM) [Time frame: Before procedure and 7 months after procedure]
• International Prostate Symptom Score I-PSS [Time frame: Before procedure and 7 months after procedure]
• Urinary flow rate [Time frame: Before procedure and 7 months after procedure]
• Post void residual volume [Time frame: Before procedure and 7 months after procedure]
• Blood loss during procedure [Time frame: During procedure]
• Hospital stay after procedure [Time frame: From end of procedure to discharge home (up to 30 days )]

Secondary outcome measures (3)

• Number of subjects with injuries related to surgical procedures. [Time frame: During procedure]
• Quality of life due to urinary symptoms [Time frame: Before procedure and 7 months after procedure]
• Number of subjects with incidental cancer [Time frame: 2 weeks after procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• UI Health SCB Clinic Department of Urology — Chicago

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. PMID 37636211
• 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. PMID 37483855

Identifiers

NCT: NCT06224218 · Study 2023-1335

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗