TerminatedNot Applicable

Prospective Cohort Study on Tolerability & Safety of Uro-Tainer® Polihexanide 0.02%

Stopped: After consultation with a medical expert the Notified Body confirmed premature termination of the study.

Belgium, Germany, Switzerland33 participantsStarted 2013-08

Plain-language summary

It is the first clinical study aimed at assessing the safety and tolerability of UT-P as routine rinsing and bacterial decolonization solution device for urinary catheters. The study will be conducted in hospitalized adult patients who had an urethral or suprapubic catheter in place for longer than two consecutive weeks and who are able to provide written consent. This is an open-label prospective observational cohort study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.

Who can participate

Age range

18 Years

Sex

ALL

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 with a sustained pain sensation in the bladder (for the first five patients). * Patients staying as inpatients with long-term (\> 2 weeks) urethral or suprapubic catheters. * Age \> 18 years * Ability to read, write and speak German or French * Women of child bearing potential must test negative on standard urine pregnancy test two weeks prior to the start of the study and must agree to practice appropriate contraceptive methods until the end of the study (e.g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence). * Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the cantonal Ethics Committee (IEC) prior to all evaluations Exclusion Criteria: * Symptomatic UTI * Hematuria * Fever (tympanic temperature \> 38.5°C) * Surgical intervention to genito-urinary tract in the last 6 months * Patients receiving any other concurrent catheter irrigation * Known allergy or sensitivity to any of the ingredients in Uro-Tainer® Polihexanide 0.02% * Known allergy or sensitivity to chlorhexidine * Pregnancy or Lactation * Simultaneous participation in another interventional trial * Administration of any other catheter irrigation 1 week prior to study * Administration of any of the following medications 4 weeks prior to study entry, unless they have been used at a stable regimen : antibiotics, antipyretics, antihista…

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

to assess the tolerability of Uro-Tainer® Polihexanide 0.02%

Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5

Trial details

NCT IDNCT02157415

SponsorB. Braun Ltd. Centre of Excellence Infection Control

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic) trials