Evaluating the Impact of Small Versus Large Urethral Stiches (or 'Bites') on Urinary Continence.
NCT ID: NCT07226687
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
338 participants
INTERVENTIONAL
2026-01-17
2031-05-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of prostate cancer with an indication for robotic-assisted radical prostatectomy (RARP).
* Ability to provide informed consent.
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Chicago
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Eggener
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB25-0202
Identifier Type: -
Identifier Source: org_study_id