Urinary Leakage in the Indwelling Urinary Catheterization (NCT04103229) | Clinical Trial Compass
CompletedNot Applicable
Urinary Leakage in the Indwelling Urinary Catheterization
128 participantsStarted 2015-04-01
Plain-language 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?
Who can participate
Age range
18 Years
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of urine leakage around the catheter
Timeframe: through study completion, about three years