The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Urinary Continence Recovery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Urinary Continence Recovery
Time Frame: One week after the removal of the suprapubic urinary catheter
24-hour pad weights
Secondary Outcomes
- Number of Participants With Urinary Continence Recovery(within 3 months from the intervention)
- Number of Participants With Peri and Postoperative Complications(1-year median follow up)
- 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)
- Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)(1-year median follow up)
- Post-operative Urinary Function and Urinary Function-related Quality of Life(Within 3 months from the intervention)
Investigators
Mani Menon
Director, Vattikuti Urology Institute
Henry Ford Health System