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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether removing a catheter at home one day after urogynecologic surgery is as safe and effective as removing it three or four days later. The goal is to determine if earlier removal aids recovery without increasing risks. Women who have undergone prolapse or anti-incontinence surgery and experience difficulty urinating independently may qualify for this study. Participants will either remove their catheter on the first day after surgery or wait until the third or fourth day. As an unphased trial, this study allows participants to contribute to important research that could enhance recovery experiences 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.

What prior data suggests that early catheter removal is safe for postoperative patients?

Research has shown that early removal of urinary catheters can be safe for patients. One study found that removing catheters at home on the first day after surgery (post-operative day one, or POD1) was as safe in preventing urination difficulties as removing them on the third or fourth day. Thus, the risk of urination issues was similar regardless of when the catheter was removed.

Another study found that earlier removal helped reduce pain from urinary tract infections (UTIs), potentially making recovery more comfortable. While early removal appears safe, individual experiences may vary. Patients should always consult their doctor to determine the best approach for their situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the early catheter removal technique for urogynecologic surgery because it could significantly reduce the discomfort and risk of infection associated with longer catheter use. Unlike the standard practice, which involves removing catheters on post-operative days 3–4, this new approach suggests removal as early as day 1. This potentially speeds up recovery and improves overall patient comfort without compromising safety.

What evidence suggests that early catheter removal is effective for postoperative urinary retention?

This trial will compare early catheter removal with standard catheter removal following urogynecologic surgery. Studies have shown that removing urinary catheters on the first day after surgery can be as effective as waiting until the third or fourth day. Research indicates that early removal does not increase the risk of urination difficulties compared to later removal. One study found that early removal helped patients leave the hospital sooner, reducing their stay by one to three days. Other research suggests that earlier removal can reduce pain from urinary tract infections (UTIs). Overall, early removal can be a safe and effective option for recovery after urogynecologic surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Lauren Tholemeier, MD

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11212151/

Evaluating the effectiveness of early urethral catheter ... The primary objective of this study is to evaluate the effectiveness and safety of early urinary catheter removal combined with IC in restoring ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06344884

Early Patient Removal of Urinary Catheters After ... Randomized, controlled, non-inferiority trial to compare the risk of urinary retention between patient urinary catheter removal on POD1 versus ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1028455924001190

Effect of early removal of urinary catheter on recovery after ... 5 studies revealed that early catheter removal significantly shortened the LOS by an average of 1–3 days (P ≤ 0.001).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37963385/

Patient Removal of Urinary Catheters After Urogynecologic ... Postoperative urinary catheter removal by the patient at home was noninferior to office removal when early urinary retention rates were compared.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/01100/the_timing_of_urinary_catheter_removal_after.71.aspx

The timing of urinary catheter removal after gynecologic... Dunn et al reported that immediate removal of urinary catheter after gynecologic surgery significantly reduced UTI-associated pain, whereas Chai et al found ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.16393

Impact of early postoperative indwelling urinary catheter ... One study (6%) found a statistically significant effect between IDUC removal after 6 h and removal the morning after surgery, with 9% and 0% ...