Clinical trial NCT06224218: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Hyperplasia
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Operative time
timeFrame: During procedure
measure: International Consultation of Incontinence Questionnaire Short Form
timeFrame: Before procedure and 7 months after procedure
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: Before procedure and 7 months after procedure
measure: International Prostate Symptom Score I-PSS
timeFrame: Before procedure and 7 months after procedure
measure: Urinary flow rate
timeFrame: Before procedure and 7 months after procedure
measure: Post void residual volume
timeFrame: Before procedure and 7 months after procedure
measure: Blood loss during procedure
timeFrame: During procedure
measure: Hospital stay after procedure
timeFrame: From end of procedure to discharge home (up to 30 days )
Secondary outcomes:
measure: Number of subjects with injuries related to surgical procedures.
timeFrame: During procedure
measure: Quality of life due to urinary symptoms
timeFrame: Before procedure and 7 months after procedure
measure: Number of subjects with incidental cancer
timeFrame: 2 weeks after procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UI Health SCB Clinic Department of Urology
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago, Department of Urology
name: Simone Crivellaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.