Evaluating the Impact of Small Versus Large Urethral Stiches (or 'Bites') on Urinary Continence.

NCT07226687 | Withdrawn

• 1 other identifier: IRB25-0202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the impact of sustainable functional urethral reconstruction (SFUR) on early recovery of urinary continence (UC) after robot-assisted radical prostatectomy.

Conditions

Prostatectomy

Keywords

Prostatectomy; Urinary continence

Outcome Measures

Primary Outcomes (1)

• Evaluating the impact of the urethral bites

  To evaluate the impact of small versus large urethral bites during vesicourethral anastomosis on urinary continence at 6 months following Robotic-assisted radical prostatectomy (RARP). Specifically, we aim to determine whether a smaller or larger suture bite technique results in superior continence recovery. This will be measured by comparing the number of incontinence pads that are needed to be used per day between each group.

  6 months following RARP

Secondary Outcomes (2)

• Assessment of urinary leaks and complications

  3 months following surgery

• Assessment of urinary leaks and complications

  12 months following surgery

Study Arms (2)

Small Bites

EXPERIMENTAL

Patients will undergo Robotic-assisted radical prostatectomy (RARP) with vesicourethral anastomosis using small urethral bites, as determined by the surgeon, with goal of being approximately 5-7 mm from the cut edge of the urethra.

Procedure: Small Urethral Bite Technique

Large Bites

EXPERIMENTAL

Patients will undergo Robotic-assisted radical prostatectomy (RARP) with vesicourethral anastomosis using large urethral bites, as determined by the surgeon, with goal of being approximately 15-20 mm from the cut edge of the urethra.

Procedure: Large Urethral Bite Technique

Interventions

Small Urethral Bite Technique PROCEDURE

The small urethral bite technique involves placing sutures (stitches) that are \~5-7 mm from the edge of the urethra. Each suture penetrates the full thickness of the urethra.

Small Bites

Large Urethral Bite Technique PROCEDURE

The large urethral bite technique involves placing sutures (stitches) that are \~15-20 mm from the edge of the urethra. Each suture penetrates the full thickness of the urethra.

Large Bites

Eligibility Criteria

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

You may qualify if:

• Male patients aged 18 years and older.
• Diagnosis of prostate cancer with an indication for robotic-assisted radical prostatectomy (RARP).
• Ability to provide informed consent.

You may not qualify if:

• History of pelvic radiation therapy
• Prostatectomy performed in the context of salvage therapy (e.g., post-radiation or post-focal therapy)
• Presence of extra-pelvic metastatic disease
• Neurological disorders significantly affecting continence (e.g., severe Parkinson's disease, multiple sclerosis)
• Pre-existing urinary incontinence
• Inability to comply with follow-up protocols

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Study Officials

• Scott Eggener

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 10, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 23, 2031
• Study Completion (Estimated): May 23, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)