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. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
Voiding trials are a routine part of Urogynecologic surgery. Management of postoperative urinary retention often requires the use of indwelling catheters. However, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. Many Urology practices allow patient removal of catheters after procedures, though this has not been formally studied. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home removal of catheter after surgery | Experimental | Patients randomized to home removal will be assigned to remove their catheters on postoperative day (POD) 2 (or if Th/F surgery, POD 4 or POD 3, respectively). They will be handed an instructional packed with visual, written and video instructions for catheter removal. |
|
| Office removal of catheter after surgery | Active Comparator | Patients randomized to office removal will be assigned to return to the office on POD 2 (or if Th/F surgery, POD 4 or POD 3, respectively) for standard nurse visit with backfill, catheter removal and voiding trial in the office. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter removal | Procedure | Catheter management strategy after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Urinary Retention in the Early Postoperative Period | The percentage of patients who have urinary retention in the early postoperative period (failed voiding trial after discharge POD 2-5) will be measured. | 2-5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of nursing calls and office visits for urinary issues in the six week postoperative period | Number of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured. | 6 week postoperative period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ijeoma Agu, MD | UNC Chapel Hill | Principal Investigator |
| Jennifer M Wu, MD, MPH | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hillsborough Hospital | Hillsborough | North Carolina | 27287 | United States | ||
| UNC Rex Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37963385 | Derived | Askew AL, Margulies SL, Agu I, LeCroy KM, Geller E, Wu JM. Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Feb 1;143(2):165-172. doi: 10.1097/AOG.0000000000005454. Epub 2023 Nov 14. |
Not provided
Not provided
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
Obtains 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.
Not provided
Not provided
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Raleigh |
| North Carolina |
| 27607 |
| United States |