Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis

NCT05605171 | Completed

• 1 other identifier: BFCRS-RP-U-01a
• Study Type: interventional
• Target: 163
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

Localized prostate cancer; Robot-assisted laparoscopic radical prostatectomy; Vesicourethral anastomosis; Posterior vesicourethral anastomosis reconstruction; Rocco stitch; Urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Return to urinary incontinence

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

  12 months post procedure

Secondary Outcomes (1)

• Need for incontinence improving procedure

  5 years post surgery

Study Arms (2)

Posterior reconstruction urethrovesical anastomosis.

EXPERIMENTAL

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.

Conventional urethrovesical anastomosis.

ACTIVE COMPARATOR

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.

Interventions

Posterior reconstruction urethrovesical anastomosis. PROCEDURE

Rocco stitch.

Posterior reconstruction urethrovesical anastomosis.

Conventional vesicourethral anastomosis. PROCEDURE

Standard of care.

Conventional urethrovesical anastomosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient over age 18 (with the ability to give informed consent) with localized prostate cancer (cT1-2, N0, M0).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bobby Shayegan, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Head, David Braley & Nancy Gordon Chair in Urology

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 4, 2022
• Study Start: March 19, 2014
• Primary Completion: November 30, 2016
• Study Completion: March 23, 2019
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share