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?

Patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.

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.

Is early removal of a Foley catheter generally safe for humans?

Research suggests that early removal of a Foley catheter, such as after colovesical fistula repair or gynecological surgery, is generally safe and does not increase complications. It may also reduce hospital stays and improve patient satisfaction. ^{1 2 3 4 5}

How does early catheter removal differ from other treatments for colovesical fistula?

Early catheter removal after colovesical fistula repair is unique because it involves taking out the urinary catheter just two days after surgery, compared to the traditional approach of leaving it in for about two weeks. This method aims to reduce complications associated with prolonged catheter use, such as infections, and improve patient comfort and recovery. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment for early catheter removal in 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 longer durations. This approach may reduce the risk of complications associated with prolonged catheter use. ^{1 3 6 9 10}

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 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 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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Removal of Indwelling Urinary Catheter Two Days After Colovesical Fistula Repair: a Single-Arm Prospective Trial. [2022]

2. Iran pubmed.ncbi.nlm.nih.gov

Post operative voiding efficacy after anterior colporrhaphy. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Colovesical fistula repair: is early Foley catheter removal safe? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Managing indwelling urethral catheters. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Enterovesical fistula as an iatrogenic complication of foley catheter use: A case report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Urinary catheters: history, current status, adverse events and research agenda. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Early and Standard Urinary Catheter Removal After Gynecological Surgery for Benign Lesions: A Quasi-Experimental Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Nurse-Driven Protocol for Foley Catheter Utilization Decreases the Incidence of Traumatic Foley Catheterization. [2021]

9. United States 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. [2022]

10. United States 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. [2021]