Albany Medical College
Albany, New York, 12208, United States
Completed
NCT Number: NCT03609476
Trial of Void With Saline Bladder Instillation
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Room temperature saline instillation
ProcedureSaline is used as room temperature
Warmed saline instillation
ProcedureSaline is warmed to 37Celcius prior to instillation
No saline instillation
ProcedureNo saline is used prior to catheter removal
Primary outcomes
-
Time from catheter removal to determination of passing void trial
Time frame: 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 outcomes
-
Catheter free rate
Time frame: 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
Time frame: 30 days
Determined at 30 day phone call to patient
-
Post void residual (PVR)
Time frame: Within 30 days
Successful PVR is <150ml or <2/3 of the voided volume
Sponsors and collaborators
Lead sponsor
Ronald Kaufman, MD
Other
Registry information
Official study title
Trial of Void With Saline Bladder Instillation, a Randomized Controlled Trial
Important dates
- Study start
- 2017
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Aug 1, 2018
- Registry last updated
- Jul 10, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.