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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04103229
Enrollment
128
Registered
2019-09-25
Start date
2015-04-01
Completion date
2019-04-30
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urine Leakage in the Indwelling Urinary Catheterization

Keywords

Urine Leakage, Indwelling urethral catheter, silicone catheter, Saline, Balloon, Distilled water

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?

Interventions

PROCEDUREThe 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.

Sponsors

Ayşe AKBIYIK
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Development of urine leakage around the catheterthrough study completion, about three yearsPatients 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026