Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis

Sponsor

St. Joseph's Healthcare Hamilton (Other)

Overall Status

Completed

CT.gov ID

NCT05605171

Collaborator

(none)

163

Enrollment

Arms

60.1

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Posterior reconstruction urethrovesical anastomosis. Procedure: Conventional vesicourethral anastomosis.	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

163 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Impact of Posterior Urethrovesical Reconstruction on Early Return to Urinary Continence Following Robot-assisted Radical Prostatectomy: a Prospective Randomized Controlled Trial

Actual Study Start Date :

Mar 19, 2014

Actual Primary Completion Date :

Nov 30, 2016

Actual Study Completion Date :

Mar 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Posterior reconstruction urethrovesical anastomosis. 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.	Procedure: Posterior reconstruction urethrovesical anastomosis. Rocco stitch.
Active Comparator: Conventional urethrovesical anastomosis. 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.	Procedure: Conventional vesicourethral anastomosis. Standard of care.

Arm

Intervention/Treatment

Experimental: Posterior reconstruction urethrovesical anastomosis.

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.

Procedure: Posterior reconstruction urethrovesical anastomosis.

Rocco stitch.

Active Comparator: Conventional urethrovesical anastomosis.

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.

Procedure: Conventional vesicourethral anastomosis.

Standard of care.

Outcome Measures

Primary Outcome Measures

Return to urinary incontinence [12 months post procedure]
The validated EPIC-26 (The Expanded Prostate Cancer Index Composite) Short Form (© The University of Michigan).

Secondary Outcome Measures

Need for incontinence improving procedure [5 years post surgery]
Midurethral sling or artificial urinary sphincter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.