Urinary Leakage in the Indwelling Urinary Catheterization

Urine Leakage in the Indwelling Urinary Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103229
• Other study ID #: EGE.0.20.05.00/OY/784/313
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2019
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urine Leakage in the Indwelling Urinary Catheterization

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ayse AKBIYIK

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of urine leakage around the catheter	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