Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05605171 |
| Other study ID # |
BFCRS-RP-U-01a |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 19, 2014 |
| Est. completion date |
March 23, 2019 |
Study information
| Verified date |
October 2022 |
| Source |
St. Joseph's Healthcare Hamilton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
