Trial of Void With Saline Bladder Instillation

July 9, 2020 updated by: Ronald Kaufman, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care group
No saline instillation
Procedure: No saline instillation
No saline is used prior to catheter removal
Active Comparator: Room temperature saline group
room temperature saline instillation
Procedure: Room temperature saline instillation
Saline is used as room temperature
Active Comparator: Warmed saline group
warmed saline instillation
Procedure: Warmed saline instillation
Saline is warmed to 37Celcius prior to instillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
Urinary tract infection free rate
Time Frame: 30 days
Determined at 30 day phone call to patient
30 days
Post void residual (PVR)
Time Frame: Within 30 days
Successful PVR is <150ml or <2/3 of the voided volume
Within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ronald Kaufman, MD

Investigators

  • Principal Investigator: Ronald P Kaufman, Jr., MD, Albany Medical College, Division of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

May 19, 2020

Study Completion (Actual)

May 19, 2020

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AMC4851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urethral Catheter Removal After Urologic Procedure

Clinical Trials on No saline instillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe