Urinary Leakage in the Indwelling Urinary Catheterization

Ayşe AKBIYIK

Status: Completed

Conditions: Urine Leakage in the Indwelling Urinary Catheterization

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04103229

EGE.0.20.05.00/OY/784/313

Details and patient eligibility

About

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?

Enrollment: 128 patients

Sex

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

10 ml sterile distilled water

Experimental group

Description:

The indwelling urinary catheterization was inflated with 10 ml sterile distilled water (SDW) of the balloon.

Treatment:

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

15 ml sterile distilled water

Experimental group

Description:

The indwelling urinary catheterization was inflated with 15 ml sterile distilled water (SDW) of the balloon.

Treatment:

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

10 ml 0.9% sodium chloride (NaCL)

Experimental group

Description:

The indwelling urinary catheterization was inflated with 10 ml 0.9% sodium chloride (NaCL) of the balloon.

Treatment:

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

15 ml 0.9% sodium chloride (NaCL)

Experimental group

Description:

The IUC was inflated with 15 ml 0.9% sodium chloride (NaCL) of the balloon.

Treatment:

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