Early Catheter Removal for Urogynecologic Surgery

(CARES2 Trial)

Overseen By Lauren Tholemeier, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-English speaking, Pregnant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

128 Participants Needed

Trial Summary

What is the purpose of this trial?

Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Early catheter removal for Urogynecologic Surgery?

Research shows that early removal of urinary catheters can reduce urinary tract infections and improve recovery after surgery. For example, studies found that early catheter removal after cesarean delivery and rectal cancer surgery led to fewer urinary symptoms and infections, suggesting similar benefits could apply to urogynecologic surgery. ^{1 2 3 4 5}

Is early catheter removal safe for patients after urogynecologic surgery?

Research suggests that early removal of urinary catheters is generally safe and may reduce the risk of urinary tract infections and other complications. Studies have shown that early removal can lead to fewer urinary symptoms and shorter hospital stays without increasing adverse events. ^{3 4 5 6 7}

How does early catheter removal differ from other treatments for urogynecologic surgery?

Early catheter removal is unique because it involves taking out the urinary catheter soon after surgery, which can help reduce the risk of urinary tract infections and speed up recovery. This approach contrasts with traditional methods that often leave the catheter in place for a longer period. ^{1 2 3 5 8}

Research Team

Lauren Tholemeier, MD

Principal Investigator

University of North Carollina at Chapel Hill

Eligibility Criteria

This trial is for women who have had prolapse or anti-incontinence surgery and can't empty their bladder properly before leaving the hospital. It's not for those who don't speak English, are pregnant, needed catheterization before surgery, got urethral injections, or had complications during surgery needing longer catheter use.

Inclusion Criteria

I am a woman who couldn't pass the urine test after prolapse or incontinence surgery.

Exclusion Criteria

Non-English speaking (due to limited resources to consent non-English speaking patients)

Pregnant

I needed a longer catheter use due to surgery complications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment/Intervention

Participants undergo urogynecologic surgery and are randomized to catheter removal on POD1 or POD3-4

1-4 days

In-person surgery and follow-up visits as needed

Postoperative Monitoring

Participants are monitored for voiding symptoms and complications, with a phone call at week 2 and an office visit at week 6

8 weeks

1 phone call, 1 in-person visit

Follow-up

Participants are monitored for postoperative complications such as UTI or urinary retention

6-8 weeks

Treatment Details

Interventions

• Early catheter removal

Trial Overview The study tests if patients removing urinary catheters at home one day after urogynecologic surgery is just as good as the standard practice of removal on days three or four by a healthcare provider in an office setting.

Participant Groups

Group I: Early Catheter Removal Experimental Treatment 1 Intervention

Participants in this arm will be asked to remove their catheters POD1.

Group II: Standard Catheter Removal Active Control 1 Intervention

Participants in this arm will be asked to remove their catheters POD3-4.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Findings from Research

In a study of 113 patients undergoing elective laparoscopic colorectal cancer surgery, early catheter removal within 24 hours was found to be safe, with only 9% experiencing postoperative urinary retention, and all patients had normal urination by the 30-day follow-up.

The standardized protocol for catheter removal effectively minimized unnecessary re-catheterizations, supporting its use in enhancing postoperative recovery in an optimal Enhanced Recovery After Surgery (ERAS) setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Urinary Retention After Laparoscopic Colorectal Resection with Early Catheter Removal: A Prospective Observational Study. Eriksen, JR., Munk-Madsen, P., Kehlet, H., et al.[2023]

In a study of 417 patients undergoing rectal resection for cancer, early urinary catheter removal on postoperative day 1 led to 59% of patients being able to void spontaneously, significantly reducing the need for additional catheterization.

The study identified five key risk factors (male gender, obesity, history of obstructive urinary disease, abdominoperineal resection, and metastatic disease) that increased the likelihood of needing in and out catheterization, with a cumulative risk of up to 68% for those with three or more risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Early Removal of Urinary Catheter Following Rectal Resection for Cancer. Duchalais, E., Larson, DW., Machairas, N., et al.[2019]

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]

Early removal of indwelling urinary catheters after elective cesarean delivery significantly reduces urinary symptoms such as dysuria and urinary frequency, based on a meta-analysis of three randomized clinical trials involving 609 participants.

The study also found that early catheter removal decreases the incidence of significant bacteriuria, suggesting it may improve overall urinary health post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed removal of indwelling urinary catheter after elective cesarean delivery: systematic review and meta-analysis of randomized controlled trials. Menshawy, A., Ghanem, E., Menshawy, E., et al.[2021]

In a study of 80 women undergoing mid-urethral sling surgery, immediate catheter removal allowed for same-day discharge without significant complications, demonstrating its safety and efficiency.

Both immediate and delayed catheter removal showed similar subjective and objective cure rates for stress incontinence after at least one year, indicating that immediate removal does not compromise treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid-urethral sling in a day surgery setting: is it possible? Braga, A., Caccia, G., Regusci, L., et al.[2021]

Early removal of indwelling urinary catheters (IDUCs) does not increase the rate of re-catheterization and is associated with quicker ambulation and shorter hospital stays, based on a review of 20 studies.

There is inconclusive evidence regarding the impact of IDUC removal timing on urinary tract infections (UTIs), but delaying removal beyond 24 hours may increase UTI risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of early postoperative indwelling urinary catheter removal: A systematic review. Nollen, JM., Pijnappel, L., Schoones, JW., et al.[2023]

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]

In a study of 124 patients who underwent transvesical adenomectomy, early catheter removal on the 5th postoperative day was found to be safe and effective, with only one case of temporary fistulization.

The early removal of the catheter led to benefits such as shorter hospital stays, reduced risk of urinary tract infections, and improved patient comfort, with 96% of patients discharged with sterile urine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early catheter removal in water-tight bladder closure following transversical prostatic adenometomy]. Patel, VJ.[2006]

References

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

Postoperative Urinary Retention After Laparoscopic Colorectal Resection with Early Catheter Removal: A Prospective Observational Study. [2023]

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

Outcomes of Early Removal of Urinary Catheter Following Rectal Resection for Cancer. [2019]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Early versus delayed removal of indwelling urinary catheter after elective cesarean delivery: systematic review and meta-analysis of randomized controlled trials. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Mid-urethral sling in a day surgery setting: is it possible? [2021]

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

Impact of early postoperative indwelling urinary catheter removal: A systematic review. [2023]

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. Germany pubmed.ncbi.nlm.nih.gov

[Early catheter removal in water-tight bladder closure following transversical prostatic adenometomy]. [2006]