Patient Removal of Catheters After Urogynecologic Surgery (CARES)

University of North Carolina (UNC)

Status: Completed

Conditions: Urinary Retention Postoperative; Patient Satisfaction

Treatments: Procedure: Catheter removal

Study type: Interventional

Funder types: Other

Identifiers

NCT04783012

20-3376

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
• 18+ years old

Exclusion criteria

• Non-English speaking
• Pregnant
• Elevated PVR (>150 mL) or dependent upon catheterization to void pre-operatively
• Urethral bulking injection surgery
• Intra-operative complication requiring prolonged catheterization
• Unable or unwilling to remove catheter at home

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Home removal of catheter after surgery

Experimental group

Description:

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.

Treatment:

Procedure: Catheter removal

Office removal of catheter after surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Catheter removal