Trial of Void With Saline Bladder Instillation

Not Applicable

Completed

• Conditions: Urethral Catheter Removal After Urologic Procedure
• Interventions: Procedure: Warmed saline instillation; Procedure: Room temperature saline instillation; Procedure: No saline instillation

• Registration Number: NCT03609476
• Lead Sponsor: Ronald Kaufman, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Primary Completion: 2020-05-19
• Study Completion: 2020-05-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warmed saline group	Warmed saline instillation	warmed saline instillation
Room temperature saline group	Room temperature saline instillation	room temperature saline instillation
Standard of care group	No saline instillation	No saline instillation

Primary Outcome Measures

Name	Time	Method
Time from catheter removal to determination of passing void trial	6 hours	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Albany Medical College; 🇺🇸 Albany, New York, United States