Trial of Void With Saline Bladder Instillation

Study Overview
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Brief Summary
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This study is being done to see if there is a difference between the traditional method of removing a urethral catheter after surgery and waiting for the patient to urinate on their own to the saline instillation method which places either room temperature or warmed saline into the patient's bladder through the catheter before removing the catheter.

Detailed Description
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Voiding trials after surgery to remove a catheter can be done in different ways. Traditional method: The catheter is removed and the patient will attempt to void. Room temperature saline instillation: Room temperature saline will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void. Warmed saline group: Saline that has been warmed to 37C will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.

Official Title
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Trial of Void With Saline Bladder Instillation, a Randomized Controlled Trial

Conditions
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Urethral Catheter Removal After Urologic Procedure

Intervention / Treatment
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* Procedure: Room temperature saline instillation
* Procedure: Warmed saline instillation
* Procedure: No saline instillation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure Exclusion Criteria: Patient incontinent at baseline. Patient has chronic indwelling urinary catheter or uses clean intermittent catheterization at home. Patient has documented neurogenic bladder. No trained person to administer the instillation or perform consent. Patient refusal to participate. Patient unable to give informed consent. Patient is a prisoner. Patient is pregnant. Patient unable to participate in notifying nursing of voids. Nursing is unable to measure post void residual with bladder scan machine secondary to body habitus or other anatomical abnormality.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care group<br>No saline instillation | Procedure: No saline instillation<br>* No saline is used prior to catheter removal<br>|
| Active Comparator: Room temperature saline group<br>room temperature saline instillation | Procedure: Room temperature saline instillation<br>* Saline is used as room temperature<br>|
| Active Comparator: Warmed saline group<br>warmed saline instillation | Procedure: Warmed saline instillation<br>* Saline is warmed to 37Celcius prior to instillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from catheter removal to determination of passing void trial | The time from when the urinary catheter is removed to a successful voiding trial defined as Void of at least 100ml AND Post Void residual (PVR) <150 or <2/3 of the voided volume | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter free rate | Subject questioned at 30 day follow up if required to have a catheter placed after leaving the hospital | 30 days | 
| Urinary tract infection free rate | Determined at 30 day phone call to patient | 30 days | 
| Post void residual (PVR) | Successful PVR is <150ml or <2/3 of the voided volume | Within 30 days |