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

February 13, 2026 updated by: University of Chicago

A Randomized Controlled Trial Evaluating the Impact of Small Versus Large Urethral Bites on Continence Outcomes After Robotic Radical Prostatectomy

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Small Bites
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
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.
Experimental: Large Bites
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the impact of the urethral bites
Time Frame: 6 months following RARP
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of urinary leaks and complications
Time Frame: 3 months following surgery
Assessing the rate of anastomotic urinary leaks and overall surgical complication rates.
3 months following surgery
Assessment of urinary leaks and complications
Time Frame: 12 months following surgery
Assessing the rate of anastomotic urinary leaks and overall surgical complication rates.
12 months following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Scott Eggener, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 23, 2031

Study Completion (Estimated)

May 23, 2031

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB25-0202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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