Urinary Leakage in the Indwelling Urinary Catheterization

Not Applicable

Completed

• Conditions: Urine Leakage in the Indwelling Urinary Catheterization
• Interventions: Procedure: The use of different types and volumes of solutions to inflate the catheter balloon

• Registration Number: NCT04103229
• Lead Sponsor: Ayşe AKBIYIK

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-04-30
• Status Verified: 2019-09
• Study First Submitted: 2019-09-22
• Study First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-25
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
15 ml 0.9% sodium chloride (NaCL)	The use of different types and volumes of solutions to inflate the catheter balloon	The IUC was inflated with 15 ml 0.9% sodium chloride (NaCL) of the balloon.
10 ml sterile distilled water	The use of different types and volumes of solutions to inflate the catheter balloon	The indwelling urinary catheterization was inflated with 10 ml sterile distilled water (SDW) of the balloon.
10 ml 0.9% sodium chloride (NaCL)	The use of different types and volumes of solutions to inflate the catheter balloon	The indwelling urinary catheterization was inflated with 10 ml 0.9% sodium chloride (NaCL) of the balloon.
15 ml sterile distilled water	The use of different types and volumes of solutions to inflate the catheter balloon	The indwelling urinary catheterization was inflated with 15 ml sterile distilled water (SDW) of the balloon.

Primary Outcome Measures

Name	Time	Method
Development of urine leakage around the catheter	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.