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

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ClinicalTrials.gov Identifier: NCT02352103
Recruitment Status : Active, not recruiting
First Posted : February 2, 2015
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mani Menon, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Retzius sparing radical prostatectomy Procedure: Vattikuti Urology Institute radical prostatectomy Device: da Vinci Surgical System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : May 2032

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
Procedure: Retzius sparing radical prostatectomy
Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing 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.




Primary Outcome Measures :
  1. Urinary Continence Recovery [ Time Frame: One week after the removal of the suprapubic urinary catheter ]
    24-hour pad weights


Secondary Outcome Measures :
  1. Number of Participants With Urinary Continence Recovery [ Time Frame: within 3 months from the intervention ]
    0 pad per day

  2. Number of Participants With Peri and Postoperative Complications [ Time Frame: 1-year median follow up ]
    Clavien-Dindo complications

  3. Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) [ Time Frame: 1-year median follow up ]
    SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED

  4. Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) [ Time Frame: 1-year median follow up ]
    Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)

  5. Post-operative Urinary Function and Urinary Function-related Quality of Life [ Time Frame: Within 3 months from the intervention ]
    International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)


Other Outcome Measures:
  1. Number of Patients Who Regained Urinary Continence Postoperatively [ Time Frame: 1 year median follow up ]
    0 pad per day

  2. Post-operative Urinary Function and Urinary Function-related Quality of Life [ Time Frame: 1 year median follow up ]
    MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352103


Locations
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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Mani Menon, MD Henry Ford Hospital
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Responsible Party: Mani Menon, Director, Vattikuti Urology Institute, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02352103    
Other Study ID Numbers: 9220
First Posted: February 2, 2015    Key Record Dates
Results First Posted: September 18, 2019
Last Update Posted: September 18, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mani Menon, Henry Ford Health System:
prostate cancer
Urinary continence
robotic assisted radical prostatectomy
Vattikuti Urology Institute (VIP) radical prostatectomy
Retzius sparing radical prostatectomy
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms