Completed

NCT Number: NCT04103229

Urinary Leakage in the 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?

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Key information

Conditions

Urine Leakage in the Indwelling Urinary Catheterization

Age range

18 year and older

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The use of different types and volumes of solutions to inflate the catheter balloon

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ayşe AKBIYIK

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Sep 25, 2019
Registry last updated: Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.