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

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

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07226687

Acronym

STITCH

Enrollment

Registered

2025-11-10

Start date

2026-09-01

Completion date

2031-05-23

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatectomy

Keywords

Prostatectomy, Urinary continence

Brief summary

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

Interventions

PROCEDURESmall 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.

PROCEDURELarge 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluating the impact of the urethral bites	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.

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORScott Eggener

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026