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Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior reconstruction urethrovesical anastomosis.
Conventional vesicourethral anastomosis.
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Localized prostate cancer, Robot-assisted laparoscopic radical prostatectomy, Vesicourethral anastomosis, Posterior vesicourethral anastomosis reconstruction, Rocco stitch, Urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Any patient over age 18 (with the ability to give informed consent) with localized prostate cancer (cT1-2, N0, M0). Exclusion Criteria: History of previous prostatic and/or urethral surgery A known history of a disease or comorbidity that could affect continence, such as insulin-dependent diabetes or urethral stenosis Presence of a urinary catheter preventing preoperative evaluation of continence.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Posterior reconstruction urethrovesical anastomosis.

    Conventional urethrovesical anastomosis.

    Arm Description

    The intervention comprised of a 2-stitch approximation of the free edge of the Denonvilliers' fascia and posterior bladder wall cranially, to the posterior aspect of the rhabdosphincter and the posterior median raphe caudally, respectively, following prostate extraction. The aim of this approach is to ultimately restore the length of the urethrosphincteric complex, prevent its caudal retraction, and avoid undue tension on the subsequent vesicourethral anastomosis, and provide a posterior support to the urethral sphincter complex to facilitate its effective contraction.

    The conventional is fashioned with a continuous running technique that uses two sutures. The first suture is passed in a clockwise hemicircumferential manner, starting from outside in on the bladder neck at the 5 o'clock position and inside out on the urethra up toward the 12 o'clock position. The second suture is similarly run in a counter- clockwise hemicircumferential direction. The running sutures are snug down after each apposition to ensure there is no slack, and finally tied together with several knots at the 12 o'clock position.

    Outcomes

    Primary Outcome Measures

    Return to urinary incontinence
    The validated EPIC-26 (The Expanded Prostate Cancer Index Composite) Short Form (© The University of Michigan).

    Secondary Outcome Measures

    Need for incontinence improving procedure
    Midurethral sling or artificial urinary sphincter

    Full Information

    First Posted
    October 23, 2022
    Last Updated
    October 28, 2022
    Sponsor
    St. Joseph's Healthcare Hamilton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05605171
    Brief Title
    Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis
    Official Title
    Impact of Posterior Urethrovesical Reconstruction on Early Return to Urinary Continence Following Robot-assisted Radical Prostatectomy: a Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 19, 2014 (Actual)
    Primary Completion Date
    November 30, 2016 (Actual)
    Study Completion Date
    March 23, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Healthcare Hamilton

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Urinary incontinence post radical prostatectomy is a well-recognized complication regardless of approach, with a potential negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in the literature, few patients are continent in the early postoperative period. It has been suggested that posterior reconstruction of the Denonvilliers' musculofascial plate, also known as the Rocco stitch, may improve early return to urinary continence, though clinical equipoise remains.
    Detailed Description
    Each modality of prostate cancer treatment has the propensity to lead to negative outcomes on quality of life to varying degrees. It is our responsibility to incorporate into our practices the most beneficial treatment regimens that render patients' cancer-free while minimizing potential treatment-related adverse outcomes, including incontinence and erectile dysfunction. Urinary incontinence and erectile dysfunction are the two most well described complications of radical prostatectomy with observed rates of 8.4% and 59.9%, respectively. Delayed recovery of urinary continence following radical prostatectomy (RP) is a well-known entity. Numerous contributing factors have been identified for post-prostatectomy incontinence (PPI), including both patient (age, body mass index, membranous urethral length, prostate volume, pre-existing lower urinary tract symptoms, and oncologic factors) and surgeon characteristics (experience, technique). In a systematic review a meta-analysis using a no pad or a single safety pad definition, Ficcara and colleagues showed that the 12-month urinary incontinence rates can range from 8% to 11%. As such, several reconstructive options have been incorporated into the contemporary RP to attempt to improve these outcomes. The anatomy of urethral-sphincteric vesico-prostatic complex is well-described, leading to attempts to perform reconstruction of the Denonvilliers' musculofascial plate during the urethrovesical anastomosis (UVA) at the time of RP. Performing a posterior reconstruction (PR) of the rhabdosphincter was first reported by Rocco et al. in 2006 during open retropubic RP, showing a 3, 30, and 90-day improvement in urinary continence post catheter removal. Posterior reconstruction urethrovesical anastomosis (PR-UVA) has been hypothesized to improve the integrity of the rhabdosphincter and potentially increase the functional urethral length. However, a recent systematic review evaluating the efficacy of PR-UVA showed no improvement in urinary continence at 1 week and 3, 6, and 12 months. Conflicting studies within the literature render an environment of clinical equipoise in this specific patient-related outcome. Our study objective was to address the true clinical benefit of the PR-UVA in a large prospective randomized controlled trial (RCT).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Localized prostate cancer, Robot-assisted laparoscopic radical prostatectomy, Vesicourethral anastomosis, Posterior vesicourethral anastomosis reconstruction, Rocco stitch, Urinary incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    163 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Posterior reconstruction urethrovesical anastomosis.
    Arm Type
    Experimental
    Arm Description
    The intervention comprised of a 2-stitch approximation of the free edge of the Denonvilliers' fascia and posterior bladder wall cranially, to the posterior aspect of the rhabdosphincter and the posterior median raphe caudally, respectively, following prostate extraction. The aim of this approach is to ultimately restore the length of the urethrosphincteric complex, prevent its caudal retraction, and avoid undue tension on the subsequent vesicourethral anastomosis, and provide a posterior support to the urethral sphincter complex to facilitate its effective contraction.
    Arm Title
    Conventional urethrovesical anastomosis.
    Arm Type
    Active Comparator
    Arm Description
    The conventional is fashioned with a continuous running technique that uses two sutures. The first suture is passed in a clockwise hemicircumferential manner, starting from outside in on the bladder neck at the 5 o'clock position and inside out on the urethra up toward the 12 o'clock position. The second suture is similarly run in a counter- clockwise hemicircumferential direction. The running sutures are snug down after each apposition to ensure there is no slack, and finally tied together with several knots at the 12 o'clock position.
    Intervention Type
    Procedure
    Intervention Name(s)
    Posterior reconstruction urethrovesical anastomosis.
    Intervention Description
    Rocco stitch.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional vesicourethral anastomosis.
    Intervention Description
    Standard of care.
    Primary Outcome Measure Information:
    Title
    Return to urinary incontinence
    Description
    The validated EPIC-26 (The Expanded Prostate Cancer Index Composite) Short Form (© The University of Michigan).
    Time Frame
    12 months post procedure
    Secondary Outcome Measure Information:
    Title
    Need for incontinence improving procedure
    Description
    Midurethral sling or artificial urinary sphincter
    Time Frame
    5 years post surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any patient over age 18 (with the ability to give informed consent) with localized prostate cancer (cT1-2, N0, M0). Exclusion Criteria: History of previous prostatic and/or urethral surgery A known history of a disease or comorbidity that could affect continence, such as insulin-dependent diabetes or urethral stenosis Presence of a urinary catheter preventing preoperative evaluation of continence.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bobby Shayegan, MD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis

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