ProstatectomySTITCHNCT07226687
Evaluating the Impact of Small Versus Large Urethral Stiches (or 'Bites') on Urinary Continence.
A study testing Small Urethral Bite Technique and Large Urethral Bite Technique in people with Prostatectomy, run by University of Chicago at 1 site in United States.
Trial summary
To evaluate the impact of sustainable functional urethral reconstruction (SFUR) on early recovery of urinary continence (UC) after robot-assisted radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatectomy
- What is being tested?
- Small Urethral Bite Technique and Large Urethral Bite Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 23 May 2031
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: 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.
- Conditions
- Prostatectomy
- Being tested
- Small Urethral Bite Technique, Large Urethral Bite Technique
- Keywords
- Prostatectomy, Urinary continence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Urethral Bite TechniqueProcedure or surgery
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 TechniqueProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Large Urethral Bite Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months following RARP
Secondary outcomes (2)
Assessment of urinary leaks and complications
Assessing the rate of anastomotic urinary leaks and overall surgical complication rates.
Measured: 3 months following surgery
Assessment of urinary leaks and complications
Assessing the rate of anastomotic urinary leaks and overall surgical complication rates.
Measured: 12 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study startSep 2026 (estimated)
- Primary completion23 May 2031 (estimated)
- Study completion23 May 2031 (estimated)
Why it stopped: Study not moving forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Eggener, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226687
- Sponsor's protocol ID
- IRB25-0202
- Acronym
- STITCH
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Impact of Small Versus Large Urethral Bites on Continence Outcomes After Robotic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07226687
- Acronym / sponsor ID
- STITCH / IRB25-0202
- Conditions
- Prostatectomy
- Keywords
- Prostatectomy, Urinary continence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not moving forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 23 May 2031 (estimated)
- Study completion
- 23 May 2031 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of sustainable functional urethral reconstruction (SFUR) on early recovery of urinary continence (UC) after robot-assisted radical prostatectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Bites | Experimental | Procedure: Small Urethral Bite TechniquePatients 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. |
| Large Bites | Experimental | Procedure: Large Urethral Bite TechniquePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Urethral Bite TechniqueThe 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. | Procedure or surgery | Small Bites |
| Large Urethral Bite TechniqueThe 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. | Procedure or surgery | Large Bites |
Primary outcome
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.
2 secondary outcomes
Assessment of urinary leaks and complications
Time frame: 3 months following surgery
Assessment of urinary leaks and complications
Time frame: 12 months following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Eggener principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Urethral Bite Technique and Large Urethral Bite Technique in people with Prostatectomy, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the impact of the urethral bites (time frame: 6 months following RARP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.