Urinary Leakage in the Indwelling Urinary Catheterization
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
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.
|
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.
|
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.
|
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
Sponsor
Investigators
- Principal Investigator: Ayse AKBIYIK, PhD, İzmir Katip Çelebi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.