Catheter Removal Timing for Urethral Stricture

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Jane Kurtzman
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal timing for removing a Foley catheter (a tube that helps drain urine) after surgery in men with a specific type of urethral stricture, which is a narrowing of the urine tube. The researchers seek to understand whether removing the catheter earlier, at 7-10 days (early catheter removal), or later, at 18-21 days (later catheter removal), affects the likelihood of complications or the recurrence of the stricture after surgery. Men who have undergone their first urethral surgery for a bulbar stricture (a narrowing in a specific part of the urethra) and have a urine test showing no infection may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially improve post-surgical outcomes for future patients.

Will I have to stop taking my current medications?

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 catheter removal timing is safe?

Research has shown that removing a catheter early, about 3 to 4 days after surgery, is usually safe. Studies have found that this timing does not significantly increase the risk of needing another catheter or cause bleeding. In fact, it might reduce the chances of developing a urinary tract infection (UTI). One study found that early removal does not increase the risk of urine leakage or recurrence of the problem.

For later catheter removal, specific data from the provided sources is lacking. However, generally, the longer a catheter remains in place, the higher the risk of infections or other complications. Both early and later removal are considered safe when performed under medical guidance, with timing mainly affecting comfort and certain risk factors.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because the timing of catheter removal could significantly impact recovery for patients with urethral strictures. Traditionally, catheter management involves a set period that doesn't account for individual healing variations. This trial explores whether removing the catheter earlier or later can lead to better outcomes, potentially reducing discomfort and complications. By fine-tuning the removal timing, there's hope for a more personalized treatment approach that could optimize patient recovery and satisfaction.

What evidence suggests that this trial's treatments could be effective for urethral stricture?

This trial will compare early catheter removal with later removal for patients with urethral stricture. Research has shown that early catheter removal can help the bladder recover faster and reduce urethral pain soon after surgery. Studies have found that early removal doesn't significantly increase the need for another catheter or cause more bleeding. Instead, it can lower the risk of urinary tract infections (UTIs). Conversely, leaving the catheter in longer might help prevent the recurrence of urethral narrowing, though success rates can vary. Both options have pros and cons, and the best timing often depends on the individual's situation.46789

Are You a Good Fit for This Trial?

This trial is for adult men with a specific type of urethral stricture who are undergoing surgery. Participants will be asked to complete surveys and attend follow-up visits. Details on inclusion and exclusion criteria were not provided.

Inclusion Criteria

Negative urine analysis or urine culture
I am having surgery for a urethral blockage near the bladder.
I am a cisgender male.
See 3 more

Exclusion Criteria

Diabetes with Hba1c greater than 8%
I have had surgery to repair the tube that carries urine from my bladder.
I have had radiation therapy to my pelvic area.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery and have a Foley catheter placed, with removal at either 7-10 days or 18-21 days post-surgery

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and follow-up visits within 12 months after surgery

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Early catheter removal
  • Later catheter removal
Trial Overview The study is testing the optimal time to remove a Foley catheter after bulbar urethroplasty by comparing two groups: one has the catheter removed at 7-10 days post-surgery, while the other at 18-21 days, to see if timing affects surgical outcomes or recurrence of narrowing.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Later RemovalExperimental Treatment1 Intervention
Group II: Early RemovalExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jane Kurtzman

Lead Sponsor

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Citations

Evaluating the effectiveness of early urethral catheter ...The primary outcome measure for this study is the rate of bladder function recovery (Bladder Function Recovery Grade II or higher) 2 weeks post- ...
Comparison of Early Clinical Outcomes in Early Versus...The initial urethral pain improved significantly after 24 h of catheter removal on either postoperative day 3 or day 6.
Review Article Early catheter removal adds no significant ...Conclu- sion: Early catheter removal does not significantly increase the risk of re-catheterization and haemorrhage while it reduces incidences of UTI and ...
Five-Year Results From the ROBUST I StudyMost failures occurred within 12 months of the Optilume DCB treatment. Anatomic success was achieved at 6 and 12 months in 76% and 70%, ...
Immediate versus early urinary catheter removal after ...Even if catheters are removed within 24 hours (h) after surgery, approximately 20% of patients will develop a UTI3, and 47–90% of patients ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/15028448/
Safety and outcome of early catheter removal after radical ...The continence and anastomotic stricture rates were improved in patients with 4 days of indwelling catheterization.
Safety and outcome of early catheter removal after radical ...Acute urinary retention after catheter removal occurred in 11 patients (3%), 4 from group 1 and 7 from group 2. None of the patients requiring catheter ...
Timing of Urinary Catheter Removal After UrethroplastyEarly catheter removal following urethroplasty does not increase the rate of extravasation or recurrence during long-term follow-up.
Comparison of continence outcomes of early catheter removal ...A recent study demonstrated that it was safe to remove catheters in most patients 3 to 4 days after RP if cystography showed no urinary ...
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