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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: Retzius sparing radical prostatectomy
* Procedure: Vattikuti Urology Institute radical prostatectomy
* Device: da Vinci Surgical System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System | Procedure: Vattikuti Urology Institute radical prostatectomy<br>* Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique<br>Device: da Vinci Surgical System<br>* 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.<br>|
| Experimental: Treatment arm<br>Retzius sparing radical prostatectomy da Vinci Surgical System | Procedure: Retzius sparing radical prostatectomy<br>* Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique<br>Device: da Vinci Surgical System<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, Urinary continence, robotic assisted radical prostatectomy, Vattikuti Urology Institute (VIP) radical prostatectomy, Retzius sparing radical prostatectomy