Trial of Void With Saline Bladder Instillation

Ronald Kaufman, MD

Status: Completed

Conditions: Urethral Catheter Removal After Urologic Procedure

Treatments: Procedure: Room temperature saline instillation; Procedure: Warmed saline instillation; Procedure: No saline instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT03609476

AMC4851

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Standard of care group

Active Comparator group

Description:

No saline instillation

Treatment:

Procedure: No saline instillation

Room temperature saline group

Active Comparator group

Description:

room temperature saline instillation

Treatment:

Procedure: Room temperature saline instillation

Warmed saline group

Active Comparator group

Description:

warmed saline instillation

Treatment:

Procedure: Warmed saline instillation