Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery

Phase 3

Completed

Interventions: Procedure: Vattikuti Urology Institute radical prostatectomy
Procedure: Retzius sparing radical prostatectomy
Device: da Vinci Surgical System

Brief Summary: To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.

Detailed Description: Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.

Recruitment & Eligibility

Inclusion Criteria

All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
Be able to read and speak English and be able to provide written informed consent

Exclusion Criteria

patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
patients participating in a competing study
patients with pre-operative urinary incontinence.

Arm && Interventions

Group	Intervention	Description
Treatment arm	da Vinci Surgical System	Retzius sparing radical prostatectomy da Vinci Surgical System
Control arm	da Vinci Surgical System	Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Control arm	Vattikuti Urology Institute radical prostatectomy	Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Treatment arm	Retzius sparing radical prostatectomy	Retzius sparing radical prostatectomy da Vinci Surgical System

Primary Outcome Measures

Name	Time	Method
Urinary Continence Recovery	One week after the removal of the suprapubic urinary catheter	24-hour pad weights

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Urinary Continence Recovery	within 3 months from the intervention	0 pad per day
Number of Participants With Peri and Postoperative Complications	1-year median follow up	Clavien-Dindo complications
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)	1-year median follow up	SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \>=22 is normal and \>=17 is considered mild ED
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)	1-year median follow up	Patients without biochemical evidence of disease recurrence (i.e. postop PSA \>=0.2 ng/mL)
Post-operative Urinary Function and Urinary Function-related Quality of Life	Within 3 months from the intervention	International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)

Locations (2): Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Henry Ford West Bloomfield Hospital
🇺🇸
West Bloomfield, Michigan, United States