Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344884
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-27
Brief Title:
Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARES2
Brief Summary:
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
Detailed 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 TreatmentIntervention
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 subjects 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 -
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 TreatmentIntervention
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 subjects 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 -
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None