Early Patient Removal of Urinary Catheters After Urogynecologic Surgery (CARES2)
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Details and patient eligibility
About
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.
Full description
Randomized, controlled, non-inferiority trial to compare the risk of urinary retention between patient urinary catheter removal on POD1 versus POD3-4 after urogynecologic surgery.
Aim One: Is the risk of urinary retention non-inferior with patient removal of transurethral catheters on POD1 versus POD3-4 after urogynecologic surgery?
Aim Two: Does healthcare resource utilization (nursing calls, patient messages, and office visits) differ between patient removal of transurethral catheters on POD1 versus POD3-4?
Aim Three: Does the patient experience differ between patient removal of transurethral catheters on POD1 versus POD3-4?
Aim Four: Does the incidence of postoperative UTI differ between patient removal of transurethral catheters on POD1 versus POD3-4?
Aim Five: Does the risk of delayed or recurrent postoperative urinary retention differ between patient removal of transurethral catheters on POD1 versus POD3-4?
Screening: Preoperative clinics at UNC Rex Urogynecology will be screened for all women who are undergoing a prolapse or anti-incontinence procedure.
Study Treatment/Intervention
Postoperatively if patients fail their voiding trial in the post-anesthesia care unit (PACU) and are willing to perform home catheter removal after instruction
Patients will be randomized to a catheter management arm: self-catheter removal on POD1 or POD3-4
POD 1 - Patients in the intervention arm will be reminded to remove their catheters
They will be instructed to remove their urinary catheter at 0700 and to call the clinic office by noon if they have not voided
If they are unable to void or have any other concerning symptoms, they will be scheduled for a same day nurse visit
Patients who are unable to void will then be taught clean intermittent self-catheterization, per usual management of postoperative voiding dysfunction
POD 3 (or by POD 4 for Thursday cases) - Patients in the control arm will be reminded to remove their catheters
* Patients undergoing surgery on Thursday will perform catheter removal on Monday. This is what was done in previous studies in order to prevent resource over-utilization on weekends. Patients undergoing surgery on Wednesday (typically only rare add-on cases) will be excluded.
They will be instructed to remove their urinary catheter at 0700 and to call the clinic office by noon if they have not voided
If they are unable to void or have any other concerning symptoms, they will be scheduled for a same day nurse visit
Patients who are unable to void will then be taught clean intermittent self-catheterization, per usual management of postoperative voiding dysfunction
Week 2 Phone Call
Patients will be called by study personnel to check in on any voiding symptoms or issues and complete phone survey regarding the following categories: Pain, Ease of use, Satisfaction, Likelihood to use again.
Week 6 Visit
Patients will have a standard office visit around 6 weeks postoperatively. At this visit, a post-void residual assessment will be performed.
Follow-up through postoperative visit after surgery
Postoperative complications, such as urinary tract infection (UTI) or delayed urinary retention will be monitored from the chart
Patients will be randomized on the day of surgery. Each subject's participation will last from the day of surgery to the day of catheter removal (on POD 1-4). They will also be called two weeks postoperatively for a check-in and survey over the phone. Postoperative complications will be monitored until their postoperative visit at 6-8 weeks after surgery.
The recruitment and data collection period is expected to last one year. The entire study including data collection, analysis and publication will take up to 3 years. -
Enrollment
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Inclusion criteria
- All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge.
Exclusion criteria
- Non-English speaking (due to limited resources to consent non-English speaking patients)
- Pregnant
- Postvoid residual (PVR) >150 mL or dependent upon catheterization to void pre-operatively
- Intra-operative complication requiring prolonged catheterization
Trial design
Primary purpose
Allocation
Interventional model
Masking
128 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Lauren Tholemeier, MD
Data sourced from clinicaltrials.gov
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