Urethral Stitch Technique for Urinary Continence After Prostatectomy

(STITCH Trial)

Overseen By Clinical Trials Intake

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Pelvic radiation, Metastatic disease, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technique to help men regain bladder control after prostate surgery. Researchers aim to determine if different stitching methods for the urethra (the tube that carries urine out of the body) aid recovery. The trial includes two groups: one uses smaller stitches, and the other uses larger stitches. This technique is called Sustainable Functional Urethral Reconstruction (SFUR). Men with prostate cancer who require surgery may be suitable candidates, particularly if they have not undergone radiation therapy. As an unphased trial, this study provides patients the chance to contribute to innovative surgical techniques that could improve recovery outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for urinary continence recovery?

Research has shown that sustainable functional urethral reconstruction (SFUR) is safe and manageable during prostate surgery. This technique helps patients regain urinary control sooner after surgery. Studies have found that patients who underwent SFUR recovered bladder control better than those who did not use this technique. No major safety concerns have been reported with SFUR, making it a promising option for improving urinary control after prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative surgical techniques for improving urinary continence after prostatectomy, a common concern for patients undergoing this procedure. Unlike traditional methods, which often focus on larger sutures to reconnect the urethra, this trial investigates the impact of using different suture sizes—small bites versus large bites—during robotic-assisted surgery. By comparing these two approaches, the trial aims to uncover whether the size of urethral sutures can significantly influence recovery and continence outcomes. This could potentially lead to more personalized and effective surgical strategies for patients.

What evidence suggests that the Sustainable Functional Urethral Reconstruction (SFUR) technique is effective for urinary continence after prostatectomy?

This trial will compare two techniques of the sustainable functional urethral reconstruction (SFUR) method: the "Small Bites" and "Large Bites" approaches. Research has shown that the SFUR technique can significantly aid early recovery of urinary control after prostate surgery. In one study, one month post-surgery, 62.3% of patients who underwent SFUR could control urination, compared to only 27.5% of those who did not. By three months, 79.2% of SFUR patients regained control, while only 63.3% of the others did. These findings suggest that SFUR may help patients regain urinary control more quickly after prostate removal surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Scott Eggener

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for men who have undergone robot-assisted radical prostatectomy, a surgical procedure to remove the prostate gland. The study aims to include those interested in testing different suture techniques that may affect urinary continence recovery.

Inclusion Criteria

Ability to provide informed consent

I am a man aged 18 or older.

I have prostate cancer and need surgery using a robot.

Exclusion Criteria

Inability to comply with follow-up protocols

I have had radiation therapy to my pelvis.

My cancer has spread beyond the pelvic area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Robotic-assisted radical prostatectomy (RARP) with vesicourethral anastomosis using either small or large urethral bites

Surgery duration

Follow-up

Participants are monitored for urinary continence and surgical complications

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Sustainable Functional Urethral Reconstruction (SFUR)

Trial Overview The trial is comparing two suture methods used during prostate surgery: Large Urethral Bite Technique versus Small Urethral Bite Technique. It's focused on seeing which one helps patients regain bladder control faster after the operation.

How Is the Trial Designed?

Group I: Small Bites Experimental Treatment 1 Intervention

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.

Group II: Large Bites Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7859366/

Maximizing early continence recovery in robotic-assisted ... In conclusion, this study proposes a new technique of sustainable functional urethral reconstruction in RARP that aims to improve early continence recovery, and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36545839/

Sustainable functional urethral reconstruction improves ... The primary outcome was the 1-month UC recovery. Secondary outcomes included short-term (≤3 months) UC recovery, urinary function, micturition-related bother, ...

3. mdpi.com mdpi.com/2077-0383/13/22/6780

Factors Contributing to Early Recovery of Urinary ... A meta-analysis of 13,749 patients showed that NS approaches had significantly higher rates of urinary continence recovery at 6 months post- ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456921001267

Patient- and Tumour-related Prognostic Factors for Urinary ... Urinary incontinence (UI) is one of the functional complications. The rate of UI at 12 mo according to a “no pad” definition ranges from 4% to 31% [1]. This ...

5. researchgate.net researchgate.net/publication/338846631_Sustainable_functional_urethral_reconstruction_Maximizing_early_continence_recovery_in_robotic-assisted_radical_prostatectomy

(PDF) Sustainable functional urethral reconstruction Immediate, 2-week, 1-month and 3-month continence recovery rates between the groups were 34.0% vs. 3.7%, 50.9% vs. 14.7%, 62.3% vs. 27.5%, and 79.2% vs. 63.3% ( ...

6. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.15956

Sustainable functional urethral reconstruction improves early ... Secondary Outcomes. Urinary Continence Recovery within 3 Months. The UC recovery rates for the SFUR vs standard groups were 53% vs 23% at 1 week ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07226687?locStr=United+States&country=United+States

Evaluating the Impact of Small Versus Large Urethral ... To evaluate the impact of small versus large urethral bites during vesicourethral anastomosis on urinary continence at 6 months following Robotic-assisted ...