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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Retzius sparing radical prostatectomy
Vattikuti Urology Institute radical prostatectomy
da Vinci Surgical System
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring prostate cancer, Urinary continence, robotic assisted radical prostatectomy, Vattikuti Urology Institute (VIP) radical prostatectomy, Retzius sparing radical prostatectomy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Henry Ford Hospital
  • Henry Ford West Bloomfield Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Treatment arm

Arm Description

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Retzius sparing radical prostatectomy da Vinci Surgical System

Outcomes

Primary Outcome Measures

Urinary Continence Recovery
24-hour pad weights

Secondary Outcome Measures

Number of Participants With Urinary Continence Recovery
0 pad per day
Number of Participants With Peri and Postoperative Complications
Clavien-Dindo complications
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
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)
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)

Full Information

First Posted
January 22, 2015
Last Updated
February 11, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02352103
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
prostate cancer, Urinary continence, robotic assisted radical prostatectomy, Vattikuti Urology Institute (VIP) radical prostatectomy, Retzius sparing radical prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Retzius sparing radical prostatectomy da Vinci Surgical System
Intervention Type
Procedure
Intervention Name(s)
Retzius sparing radical prostatectomy
Intervention Description
Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
Intervention Type
Procedure
Intervention Name(s)
Vattikuti Urology Institute radical prostatectomy
Intervention Description
Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
Intervention Type
Device
Intervention Name(s)
da Vinci Surgical System
Intervention Description
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 Measure Information:
Title
Urinary Continence Recovery
Description
24-hour pad weights
Time Frame
One week after the removal of the suprapubic urinary catheter
Secondary Outcome Measure Information:
Title
Number of Participants With Urinary Continence Recovery
Description
0 pad per day
Time Frame
within 3 months from the intervention
Title
Number of Participants With Peri and Postoperative Complications
Description
Clavien-Dindo complications
Time Frame
1-year median follow up
Title
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
Description
SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED
Time Frame
1-year median follow up
Title
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
Description
Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)
Time Frame
1-year median follow up
Title
Post-operative Urinary Function and Urinary Function-related Quality of Life
Description
International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)
Time Frame
Within 3 months from the intervention
Other Pre-specified Outcome Measures:
Title
Number of Patients Who Regained Urinary Continence Postoperatively
Description
0 pad per day
Time Frame
1 year median follow up
Title
Post-operative Urinary Function and Urinary Function-related Quality of Life
Description
MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function
Time Frame
1 year median follow up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mani Menon, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28483330
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.
Results Reference
result
PubMed Identifier
29225060
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28483330/
Description
A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy
URL
https://pubmed.ncbi.nlm.nih.gov/29225060/
Description
Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches

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

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