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

The University of Chicago

Status: Begins enrollment in 6 months

Conditions: Prostatectomy

Treatments: Procedure: Large Urethral Bite Technique; Procedure: Small Urethral Bite Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07226687

IRB25-0202

Details and patient eligibility

About

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

Enrollment: 338 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

Small Bites

Experimental group

Description:

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.

Treatment:

Procedure: Small Urethral Bite Technique

Large Bites

Experimental group

Description:

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.

Treatment:

Procedure: Large Urethral Bite Technique