Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06224218
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostate Single Port & Laser Enucleation Comparison Trial
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Randomized Controlled Trial Comparing Single Port Simple Prostatectomy and Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: