Urinary Leakage in the Indwelling Urinary Catheterization

September 24, 2019 updated by: Ayşe AKBIYIK

Investigation of Two Different Types of Solution and Volume for Inflating Foley Catheter Balloon in Indwelling Urinary Catheterization

In the indwelling urinary catheterization (IUC), urinary leakage may develop around the catheter in the following days of catheterization. The volume and type of fluid used to inflate the catheter balloon has the potential to be a factor in the development of this problem.

In this study, the investigators aimed to investigate the effect of the type and amount of fluid used in inflating the silicone foley catheter balloon on the development of urinary leakage around the catheter. In addition to purpose, the following questions were answered to determine the optimal solution type and volume in inflating the balloon:

  • What was the incidence of urinary leakage in IUC?
  • Was there a relationship between catheterization time and urine leakage?
  • Was there a relationship between the type of fluid used to inflate the foley catheter balloon and urine leakage?
  • Was there a relationship between the amount of fluid used to inflate the foley catheter balloon and urine leakage?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  • Patients over the age of 18 years,
  • Patients with indication for IUC (presence of order),
  • Patients eligible for the use of a 18 Fr silicone foley catheter,
  • Patients who did not have a problem that could affect prostate hypertrophy and/or urinary system miction.

Exclusion Criteria:

  • In the study, if urine leakage occurred within 12 hours after catheterization, it was assumed that the leakage was caused by the size of the catheter, and these patients/patients were excluded from the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 ml sterile distilled water
The indwelling urinary catheterization was inflated with 10 ml sterile distilled water (SDW) of the balloon.
Procedure: The use of different types and volumes of solutions to inflate the catheter balloon
In catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned.
Experimental: 15 ml sterile distilled water
The indwelling urinary catheterization was inflated with 15 ml sterile distilled water (SDW) of the balloon.
Procedure: The use of different types and volumes of solutions to inflate the catheter balloon
In catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned.
Experimental: 10 ml 0.9% sodium chloride (NaCL)
The indwelling urinary catheterization was inflated with 10 ml 0.9% sodium chloride (NaCL) of the balloon.
Procedure: The use of different types and volumes of solutions to inflate the catheter balloon
In catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned.
Experimental: 15 ml 0.9% sodium chloride (NaCL)
The IUC was inflated with 15 ml 0.9% sodium chloride (NaCL) of the balloon.
Procedure: The use of different types and volumes of solutions to inflate the catheter balloon
In catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of urine leakage around the catheter
Time Frame: through study completion, about three years

Patients were followed up every 12 hours for the presence of urine leakage around the catheter. The presence of urine leakage was monitored by macroscopic examination, wetting of the diaper, and pH meter strip wrapped around the catheter. In addition, urine samples of the urine leakage were collected, and urine pH and leakage pH were compared.

Participation of the patients in the study groups was continued until one or more of the following criteria met:

Urinary leakage around the catheter, Termination of catheterization, Transferring the patient to another unit, Development of Exitus.
through study completion, about three years

Collaborators and Investigators

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

Sponsor

Ayşe AKBIYIK

Investigators

  • Principal Investigator: Ayse AKBIYIK, PhD, Izmir Katip Çelebi University

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)

April 1, 2015

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

September 22, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EGE.0.20.05.00/OY/784/313

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.

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