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Trial of Void With Saline Bladder Instillation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03609476
Enrollment
108
Registered
2018-08-01
Start date
2017-05-24
Completion date
2020-05-19
Last updated
2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Catheter Removal After Urologic Procedure

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.

Interventions

PROCEDURERoom temperature saline instillation

Saline is used as room temperature

PROCEDUREWarmed saline instillation

Saline is warmed to 37Celcius prior to instillation

PROCEDURENo saline instillation

No saline is used prior to catheter removal

Sponsors

Ronald Kaufman, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time from catheter removal to determination of passing void trial6 hoursThe 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

MeasureTime frameDescription
Catheter free rate30 daysSubject questioned at 30 day follow up if required to have a catheter placed after leaving the hospital
Urinary tract infection free rate30 daysDetermined at 30 day phone call to patient
Post void residual (PVR)Within 30 daysSuccessful PVR is \<150ml or \<2/3 of the voided volume

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026