Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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. -
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Catheter Removal | Experimental | Participants in this arm will be asked to remove their catheters POD1. |
|
| Standard Catheter Removal | No Intervention | Participants in this arm will be asked to remove their catheters POD3-4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early catheter removal | Procedure | Catheter removal the day after surgery as opposed to standard of care (3 to 4 days after surgery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with ongoing urinary retention (noninferiority) | Defined as need for catheter replacement or clean intermittent self catheterization (CISC) after catheter removal on POD1 vs POD3-4. A 95% confidence interval of the difference in proportions between the two groups will be used to assess the tenability of a non-inferiority proposition. | From Postoperative day 1 through postoperative week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient contacts for voiding dysfunction by Type | Nursing calls, patient messages, and/or office visits will be summarized. | From Postoperative day 1 through postoperative week 8 |
| Total patient contacts for voiding dysfunction Combined |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lauren Tholemeier, MD | University of North Carollina at Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Health Rex | Raleigh | North Carolina | 27607 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Beginning 9 to 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Not provided
Not provided
Randomized
Not provided
Not provided
Not provided
Not provided
The total number of nursing calls, patient messages, and/or office visits combined.
| From Postoperative day 1 through postoperative week 8 |
| Number of patients treated for postoperative UTI. | A case of postoperative UTI will be defined by patient receiving antibiotic treatment for UTI. This typically happens as a result of patient symptoms and/or a positive urine culture. | From Postoperative day 1 through postoperative week 8 |
| Number of patients with ongoing urinary retention | Defined as need for catheter replacement or clean intermittent self catheterization (CISC) after catheter removal on POD 1 vs 3-4. | From Postoperative day 1 through postoperative week 8 |
| Patient Satisfaction Survey Score-Pain | One survey question will be asked regarding Pain on a Likert Scale. The question is scored 0-4 with a higher score representing more pain. | Postoperative week 2 |
| Patient Satisfaction Survey Score-Ease of Use | One survey question will be asked regarding Ease of use on a Likert Scale. The question is scored 0-4 with a higher score meaning more difficulty or a worse outcome. | Postoperative week 2 |
| Patient Satisfaction Survey Score-Satisfaction | One survey question will be asked regarding Satisfaction on a Likert Scale. The question is scored 0-3 with a higher score meaning more satisfied or a better outcome. | Postoperative week 2 |
| Patient Satisfaction Survey Score-Likelihood to Use Again | One survey question will be asked regarding likelihood to use again on a Likert Scale. The question is scored 0-3 with a higher score meaning more likely or a better outcome. | Postoperative week 2 |