Clinical trial NCT02352103: Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
Official title: The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Keywords: prostate cancer
Urinary continence
robotic assisted radical prostatectomy
Vattikuti Urology Institute (VIP) radical prostatectomy
Retzius sparing radical prostatectomy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary Continence Recovery
timeFrame: One week after the removal of the suprapubic urinary catheter
Secondary outcomes:
measure: Number of Participants With Urinary Continence Recovery
timeFrame: within 3 months from the intervention
measure: Number of Participants With Peri and Postoperative Complications
timeFrame: 1-year median follow up
measure: Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
timeFrame: 1-year median follow up
measure: Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
timeFrame: 1-year median follow up
measure: Post-operative Urinary Function and Urinary Function-related Quality of Life
timeFrame: Within 3 months from the intervention
Other outcomes:
measure: Number of Patients Who Regained Urinary Continence Postoperatively
timeFrame: 1 year median follow up
measure: Post-operative Urinary Function and Urinary Function-related Quality of Life
timeFrame: 1 year median follow up
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Mani Menon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.