Early Catheter Removal for Urogynecologic Surgery
(CARES2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Disqualifiers: Non-English speaking, Pregnant, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
34567How 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.
12358Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Catheter RemovalExperimental Treatment1 Intervention
Participants in this arm will be asked to remove their catheters POD1.
Group II: Standard Catheter RemovalActive Control1 Intervention
Participants in this arm will be asked to remove their catheters POD3-4.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UNC Health RexRaleigh, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
References
Postoperative Urinary Retention After Laparoscopic Colorectal Resection with Early Catheter Removal: A Prospective Observational Study. [2023]Early catheter removal is essential to enhance postoperative mobilization and recovery, but may carry a risk of urinary retention. This study aimed to evaluate a standardized regimen for early postoperative catheter removal and re-catheterization in patients undergoing elective laparoscopic colorectal cancer surgery within an optimal ERAS setting.
Outcomes of Early Removal of Urinary Catheter Following Rectal Resection for Cancer. [2019]Early postoperative urinary catheter removal decreases urinary tract infection (UTI) rate and accelerates patient mobilization. The aim of this study is to determine the results of systematic urinary catheter removal on postoperative day (POD) 1 in patients undergoing rectal resection for cancer.
Implementation of a Nurse-Driven Protocol for Catheter Removal to Decrease Catheter-Associated Urinary Tract Infection Rate in a Surgical Trauma ICU. [2022]Early removal of urinary catheters is an effective strategy for catheter-associated urinary tract infection (CAUTI) prevention. We hypothesized that a nurse-directed catheter removal protocol would result in decreased catheter utilization and CAUTI rates in a surgical trauma intensive care unit (STICU).
Early versus delayed removal of indwelling urinary catheter after elective cesarean delivery: systematic review and meta-analysis of randomized controlled trials. [2021]Background: Timing of removal of the indwelling urinary catheter after elective cesarean delivery (CD) is controversial. Early removal could be associated with fewer urinary symptoms.Objective: This review aims to evaluate the evidence from published randomized clinical trials (RCTs) about the outcomes of early versus delayed removal of indwelling urinary catheter after elective cesarean delivery (CD).Data sources: Electronic databases were searched using the following MeSH terms (early Or Late Or immediate OR delayed removal) AND (Urinary catheter) AND (cesarean section OR cesarean delivery OR CS)Methods of study selection: All RCTs assessing the timing of removal of urinary catheter were considered for this meta-analysis. One hundred seventy-two studies were identified of which three studies deemed eligible for this review. Quality and risk of bias assessment were performed for all studies.Data extraction: Two researchers independently extracted the data from the individual articles and entered into RevMan software. The relative risk (RR), the weighted mean difference (WMD) and 95% confidence interval (CI) were calculated. The extracted outcomes were significant bacteriuria, urinary symptoms (urinary retention necessitating re-catheterization, dysuria, urinary frequency, urgency) postoperative oral rehydration and length of hospital stay.Results: Three RCTs (early removal: n = 298 and delayed removal: n = 311) were included. The pooled estimate showed that early removal significantly reduced dysuria (RR = 0.60, 95% CI [0.38, 0.95], p=.03), urinary frequency (RR = 0.32, 95% CI [0.16, 0.66], p=.002) and significant bacteriuria (RR = 0.49, 95% CI [0.30, 0.83], p=.007) than delayed removal.Conclusions: This meta-analysis suggests that early removal of the indwelling urinary catheter in patients who underwent elective CD showed significant less dysuria, less urinary frequency and a decrease in the incidence of significant bacteriuria.
Mid-urethral sling in a day surgery setting: is it possible? [2021]Several studies have shown that immediate catheter removal following pelvic surgery is associated with several advantages. The aim of this case-control study is to compare immediate versus delayed catheter removal following mid-urethral sling surgery, to determine if indwelling catheterisation is necessary after this procedure. The secondary outcomes were subjective and objective cure rate after at least a 1-year follow-up.
Impact of early postoperative indwelling urinary catheter removal: A systematic review. [2023]Indwelling urinary catheters (IDUCs) are associated with complications and early removal is therefore essential. Currently, it is unknown what the effect of a specific removal time is and what the consequences of this removal time are.
Early and Standard Urinary Catheter Removal After Gynecological Surgery for Benign Lesions: A Quasi-Experimental Study. [2022]Patients undergoing gynecological surgery commonly receive indwelling transurethral Foley catheters, however duration of catheterization is associated with risk of urinary tract infections and other adverse effects. Early removal of catheters is encouraged, however optimal timing postsurgery remains unclear. This quasi-experimental study compared outcomes for women after removal of a Foley catheter at two different times following benign gynecological surgery. Participants received either early catheter removal, within 6 hours of surgery (n = 38) or standard catheter removal, within 12 to 24 hours of surgery (n = 45). There were no significant differences in outcomes for discomfort scores or re-catheterization rates between groups. However, the early removal group had a significantly shorter time to first ambulation and shorter hospital stays. Early removal of Foley catheters in patients who underwent gynecological surgery did not increase adverse events. Early removal of catheters after gynecological surgery may decrease re-catheterization rates and increase patient satisfaction.
[Early catheter removal in water-tight bladder closure following transversical prostatic adenometomy]. [2006]It is reported on 124 patients in whom after a transvesical adenomectomy an early removal of the catheter was aspired to. A watertight closure of the urinary bladder is one of the most important prerequisites. The 5th day after operation seems to be best suited for the removal of the catheter. A temporary fistulisation lasting 2 days occurred only in one case. Secondary infection of the wound as well as epididymitis could not be observed. 96% of the patients could be discharged with sterile urine. Advantages of the early removal of the catheter: 1. Shortened hospitalisation and shortened convalesence. 2. Reduced danger of a secondary infection of the urinary tract 3. Early symptom-free subjective condition of the patient.