Early Catheter Removal for Colovesical Fistula

Overseen By Karim Alavi, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Karim Alavi

Disqualifiers: Genitourinary cancers, Inflammatory Bowel Disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety of removing a bladder catheter earlier than usual after surgery to repair a colovesical fistula (an abnormal connection between the colon and bladder). Typically, the catheter remains in place for about 11 days, but this study tests removal on day 2 or 3 post-surgery. The trial seeks adults undergoing surgery to repair a colovesical fistula caused by diverticulitis. As an unphased trial, it offers patients the chance to contribute to medical knowledge and potentially enhance recovery times 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 early Foley catheter removal is safe for patients with colovesical fistula?

Research has shown that removing a Foley catheter (a tube that drains urine from the bladder) soon after surgery for a colovesical fistula (an unusual link between the colon and bladder) is safe. Several studies indicate that removing the catheter just a few days post-surgery does not increase complications. In fact, patients who had their catheters removed early experienced no more complications than those who had them removed later. Overall, early removal appears to be a well-tolerated option for patients recovering from this type of surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the early removal of the Foley catheter for colovesical fistula (CVF) because it significantly shortens the time patients need to have a catheter post-surgery. Traditionally, patients keep the catheter for over 10 days after CVF repair, but this approach reduces it to just 2 or 3 days. This quicker removal could lead to faster recovery, lower risk of infections, and improved comfort for patients. By potentially enhancing recovery without compromising safety, these adjustments to post-operative care could mark a meaningful improvement in managing colovesical fistulas.

What evidence suggests that early Foley catheter removal is effective for colovesical fistula?

This trial will evaluate the early removal of a Foley catheter, specifically within two to three days after surgery for a colovesical fistula. Research has shown that early removal is safe and does not lead to more complications than leaving it in longer. In fact, removing it sooner may aid in faster recovery. Patients in earlier studies who had their catheter removed early did not experience more issues. Overall, early removal of the Foley catheter appears to be a safe and promising option. ^{2 3 4 6 7}

Who Is on the Research Team?

KArin Alavi, MD, MPH

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having surgery to fix a diverticular colovesical fistula, which is an abnormal connection between the colon and bladder. It's not for those with bowel inflammation diseases, untreated genital cancers, pregnant women, prisoners, minors or anyone unable to consent.

Inclusion Criteria

I am an adult having surgery for a specific bowel-bladder connection.

Exclusion Criteria

Prisoners

I am under 18 years old.

I won't regain normal bladder function after surgery due to existing bladder issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Post-operative Care

Participants undergo surgical repair of colovesical fistula and have early foley catheter removal on post-operative day 3

3 days

In-patient hospital stay

Follow-up

Participants are monitored for bladder leaks, urinary tract infections, and other adverse events post-surgery

30 days

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Removal of Foley Catheter

Trial Overview The study tests if removing the Foley catheter (a tube inserted into the bladder) early—2 to 3 days after surgery—is safe compared to later removal. Outcomes will be measured against past data from patients who had their catheters removed later.

How Is the Trial Designed?

Group I: Foley catheter removal day 2 or 3 post-operative procedure Experimental Treatment 1 Intervention

According to review of internal clinical practices, the average duration of catheterization after Colovesical Fistula (CVF) repair is 10.8 days after CVF repair. The intervention in this study removes the Foley Catheter at 2 to 3 days post CVF repair.

Who Is Running the Clinical Trial?

Karim Alavi

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 189 patients undergoing anterior and posterior colporrhaphy, removing the urinary Foley catheter on the fourth day post-surgery significantly reduced the need for repeated catheterization, with no increased risk of urinary infection.

Patients who had their catheters removed on day four showed a 0% rate of needing a repeat Foley catheter when their residual urine volume was 33% or less, compared to higher rates of repeat catheterization for those removed earlier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post operative voiding efficacy after anterior colporrhaphy. Kokabi, R., Fereidouni, Z., Meshkibaf, MH., et al.[2010]

In a study of 120 live donor kidney transplant recipients, removing Foley catheters on postoperative day 1 did not increase the risk of urine leaks, suggesting it is a safe practice.

Early removal of Foley catheters is associated with increased patient comfort, improved mobility, and a reduced risk of urinary tract infections, potentially leading to shorter hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Removal of foley catheters in live donor kidney transplant recipients on postoperative day 1 does not increase the incidence of urine leaks. Siskind, E., Sameyah, E., Goncharuk, E., et al.[2021]

In a study of 24 patients with colovesical fistulas due to diverticular disease, removing the Foley catheter on postoperative day two was found to be safe and feasible, with 96% of patients successfully having it removed after a negative cystogram.

No complications were reported following the early catheter removal, and the average hospital stay was 4.3 days, suggesting that this approach could improve recovery times and reduce hospital stays for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Removal of Indwelling Urinary Catheter Two Days After Colovesical Fistula Repair: a Single-Arm Prospective Trial. Holland, C., Vabi, BW., Shenoy, PP., et al.[2022]

In a study of 32 patients with colovesical fistula (CVF) due to diverticulitis, early removal of the Foley catheter (within 7 days) did not lead to increased complications compared to late removal (beyond 7 days).

Postoperative cystograms, performed to check for bladder leaks, showed no value in patients with simple bladder repairs, as all results were negative, suggesting they may not be necessary in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colovesical fistula repair: is early Foley catheter removal safe? de Moya, MA., Zacharias, N., Osbourne, A., et al.[2022]

In a study of 83 women undergoing benign gynecological surgery, early removal of Foley catheters within 6 hours did not lead to more discomfort or higher re-catheterization rates compared to standard removal after 12 to 24 hours.

Patients with early catheter removal experienced quicker ambulation and shorter hospital stays, suggesting that this practice may enhance patient satisfaction and reduce the risk of urinary tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and Standard Urinary Catheter Removal After Gynecological Surgery for Benign Lesions: A Quasi-Experimental Study. Chen, SF., Wang, PH., Kuo, SC., et al.[2022]

Indwelling urethral (Foley) catheters, designed for bladder drainage, are increasingly used in elderly patients, particularly in home care settings, due to rising numbers of individuals with urinary issues.

Despite their utility, Foley catheters are linked to various complications that can increase patient morbidity and mortality, highlighting the need for effective management strategies and retraining after catheter removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing indwelling urethral catheters. Newman, DK.[2007]

A nurse-directed protocol for early urinary catheter removal significantly reduced catheter utilization in a surgical trauma intensive care unit, from 0.78 to 0.70 catheters per patient.

The implementation of this protocol also led to a significant decrease in catheter-associated urinary tract infection (CAUTI) rates, dropping from 5.1 to 2.0 infections per 1000 catheter-days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Nurse-Driven Protocol for Catheter Removal to Decrease Catheter-Associated Urinary Tract Infection Rate in a Surgical Trauma ICU. Tyson, AF., Campbell, EF., Spangler, LR., et al.[2022]

The use of Foley catheters, while common for indwelling bladder drainage, is associated with serious complications such as infections, kidney damage, and significant healthcare costs, amounting to £1.0-2.5 billion annually in the UK and approximately 2100 deaths per year.

There is an urgent need for a new indwelling catheter system that is safer and more effective, with features that allow for easy insertion, reliable retention, and natural bladder function, to reduce the risks associated with current catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary catheters: history, current status, adverse events and research agenda. Feneley, RC., Hopley, IB., Wells, PN.[2022]

Enterovesical fistulas, a rare but serious complication of long-term indwelling urinary catheters, can lead to significant health risks and often require emergency surgery.

In a case study of an elderly nursing home resident, the presence of a Foley catheter bulb in the small bowel was successfully managed through open repair of the bladder and partial small bowel resection, highlighting the need for prompt diagnosis and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enterovesical fistula as an iatrogenic complication of foley catheter use: A case report. Hobday, A., Chung, M., Rola, D., et al.[2022]

A nurse-driven protocol implemented in May 2015 successfully reduced the average monthly use of Foley catheters from 2,903 to 2,604 patient-catheterization days, indicating a significant decrease in unnecessary catheterizations (P<0.01).

The incidence of Foley catheter-associated trauma also significantly decreased from an average of 1.81 traumas per month to 0.97 traumas per month after the protocol was put in place (P<0.05), demonstrating improved patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nurse-Driven Protocol for Foley Catheter Utilization Decreases the Incidence of Traumatic Foley Catheterization. Laborde, E., Hill, H., Dukovac, TE., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23015147

Removal of Indwelling Urinary Catheter Two Days After ... Several retrospective studies have indicated “early” Foley catheter removal (i.e., ≤ 7 days) produces favorable outcomes, but imaging performed was variable and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05235204

Early Foley Catheter Removal After Diverticular ... Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe. Detailed Description.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36138309/

Removal of Indwelling Urinary Catheter Two Days After ... Foley catheter removal after negative cystogram on postoperative day two appears to be feasible and safe in the setting of diverticulitis-related colovesical ...

4. withpower.com withpower.com/trial/phase-intestinal-fistula-2-2019-c8d56

Early Catheter Removal for Colovesical Fistula Research suggests that early removal of a Foley catheter after colovesical fistula repair is feasible and safe, with no increase in complications compared to ...

5. researchgate.net researchgate.net/publication/26727611_Colovesical_Fistula_Repair_Is_Early_Foley_Catheter_Removal_Safe1

Colovesical Fistula Repair: Is Early Foley Catheter ... Recent studies favored early removal of Foley catheter within seven days, as it was not associated with an increase in complications [14] .

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19665732/

Colovesical fistula repair: is early Foley catheter removal ... Patients with early Foley catheter removal did not have significant complications compared with patients with late Foley catheter removal. Eleven patients got ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05235204/early-foley-catheter-removal-after-diverticular-colovesical-fistula-repair

Early Foley Catheter Removal After Diverticular ... Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.