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

The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Procedure: Vattikuti Urology Institute radical prostatectomy; Device: da Vinci Surgical System; Procedure: Retzius sparing radical prostatectomy

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System	Procedure: Vattikuti Urology Institute radical prostatectomy; Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique; Device: da Vinci Surgical System; The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
Experimental: Treatment arm; Retzius sparing radical prostatectomy da Vinci Surgical System	Device: da Vinci Surgical System; The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.; Procedure: Retzius sparing radical prostatectomy; Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Continence Recovery	24-hour pad weights	One week after the removal of the suprapubic urinary catheter

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Regained Urinary Continence Postoperatively	0 pad per day	1 year median follow up
Post-operative Urinary Function and Urinary Function-related Quality of Life	MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function	1 year median follow up

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Mani Menon, MD, Henry Ford Hospital

Publications and helpful links

General Publications

• Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, Menon M. A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Nov;72(5):677-685. doi: 10.1016/j.eururo.2017.04.029. Epub 2017 May 6.
• Menon M, Dalela D, Jamil M, Diaz M, Tallman C, Abdollah F, Sood A, Lehtola L, Miller D, Jeong W. Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches. J Urol. 2018 May;199(5):1210-1217. doi: 10.1016/j.juro.2017.11.115. Epub 2017 Dec 7.

Helpful Links

• A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy
• Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: prostate cancer; Urinary continence; robotic assisted radical prostatectomy; Vattikuti Urology Institute (VIP) radical prostatectomy; Retzius sparing radical prostatectomy
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: 9220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided