Completed

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

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What is being tested

Room temperature saline instillation

+ Warmed saline instillation

+ No saline instillation

Procedure
Who is being recruted

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: May 2017
See protocol details

Summary

Principal SponsorRonald Kaufman, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 24, 2017

Actual date on which the first participant was enrolled.

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 TitleTrial of Void With Saline Bladder Instillation, a Randomized Controlled Trial
NCT03609476
Principal SponsorRonald Kaufman, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure
10 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
room temperature saline instillation

Group II

Active Comparator
warmed saline instillation

Group III

Active Comparator
No saline instillation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Albany Medical College

Albany, United StatesOpen Albany Medical College in Google Maps
CompletedOne Study Center