Patient Removal of Catheters After Urogynecologic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial

Conditions
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Urinary Retention Postoperative, Patient Satisfaction

Intervention / Treatment
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* Procedure: Catheter removal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home removal of catheter after surgery<br>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. | Procedure: Catheter removal<br>* Catheter management strategy after surgery<br>|
| Active Comparator: Office removal of catheter after surgery<br>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. | Procedure: Catheter removal<br>* Catheter management strategy after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |