NCT04103229

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

September 22, 2019

Last Update Submit

September 24, 2019

Conditions

Urine Leakage in the Indwelling Urinary Catheterization

Keywords

Urine LeakageIndwelling urethral cathetersilicone catheterSalineBalloonDistilled water

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

10 ml sterile distilled water

EXPERIMENTAL

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

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

15 ml sterile distilled water

EXPERIMENTAL

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

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

10 ml 0.9% sodium chloride (NaCL)

EXPERIMENTAL

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

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

15 ml 0.9% sodium chloride (NaCL)

EXPERIMENTAL

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

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

Interventions

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

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.

10 ml 0.9% sodium chloride (NaCL)10 ml sterile distilled water15 ml 0.9% sodium chloride (NaCL)15 ml sterile distilled water

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details64 male and 64 female patients were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ayse AKBIYIK, PhD

    İzmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of Philosophy (PhD) Research Assistant

Study Record Dates

First Submitted

September 22, 2019

First Posted

September 25, 2019

Study Start

April 1, 2015

Primary Completion

January 31, 2019

Study Completion

April 30, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share