Prostate Single Port & Laser Enucleation Comparison Trial

NCT ID: NCT06224218

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-08-15

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.

Conditions

Prostate Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Port Robotic Prostatectomy

Removal of the prostate using single port robot

Group Type: ACTIVE_COMPARATOR

Single Port Robotic Surgery

Intervention Type: PROCEDURE

Single port Robotic surgery will remove the whole prostate

Laser Enucleation of the Prostate

Enucleation of the prostate with laser surgery

Group Type: ACTIVE_COMPARATOR

Laser Surgery

Intervention Type: PROCEDURE

Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.

Interventions

Single Port Robotic Surgery

Single port Robotic surgery will remove the whole prostate

Intervention Type: PROCEDURE

Laser Surgery

Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Simone Crivellaro

Urology Dpt, Vice Chair, Lawrence S. Ross Endowed Professor & Associate Professor of Urology Robotic, Section Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Crivellaro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago, Department of Urology

Locations

UI Health SCB Clinic Department of Urology

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ruben Sauer, MD

Role: CONTACT

rsauer1@uic.edu

3124135288

Facility Contacts

Ruben Sauer, MD

Role: primary

rsauer1@uic.edu

312-413-5288

References

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.

Reference Type: RESULT

PMID: 37636211 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37483855 (View on PubMed)

Other Identifiers

Study 2023-1335

Identifier Type: -

Identifier Source: org_study_id