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

Henry Ford Health

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02352103

9220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Control arm

Active Comparator group

Description:

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Treatment:

Procedure: Vattikuti Urology Institute radical prostatectomy

Device: da Vinci Surgical System

Treatment arm

Experimental group

Description:

Retzius sparing radical prostatectomy da Vinci Surgical System

Treatment:

Procedure: Retzius sparing radical prostatectomy

Device: da Vinci Surgical System