Comparison of Microtrauma in Urethra After Usage of Different Catheters (NCT01600443) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Microtrauma in Urethra After Usage of Different Catheters
Stopped: Planned interim analysis showed study was underpowered
Sweden21 participantsStarted 2012-04
Plain-language summary
The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study.
Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week.
The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization.
The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization.
The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality.
The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.
Who can participate
Age range
18 Years
Sex
MALE
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
. Provision of informed consent
. Healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half \>50 years old)
. Negative urine dipstick test (no blood in the urine) before randomization
Exclusion criteria
. Intake of anticoagulants at enrolment and during the study period
. Intake of antibiotics at enrolment and during the study period
. Urinary tract infection (UTI) at enrolment and during the study period
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
Hematuria
Timeframe: Approximately 2 hours after last catheterization