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.
The objective of this study is to assess the tolerability and safety of Uro-Tainer® Polihexadine 0.02% intended as routine rinsing and bacterial decolonization of urinary catheters in long-term catheterized patients. After each instillation patients will be assessed for vital signs, skin reactions and other symptoms suggesting intolerance or sensitivity and/or allergic reaction. In addition, pain will be assessed in the first 5 patients and any other patients with sustained pain sensation in the bladder. Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a maximum of 5 instillations. A minimum interval of 24 hours must be guaranteed for the enrolment of the first 5 patients and their first irrigation with the investigational product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
33
Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a maximum of 5 instillations.
Universitair Ziekenhuis
Ghent, Belgium
Kliniken-Beelitz GmbH
Beelitz-Heilstätten, Germany
Schweizerisches Paraplegikerzentrum
Basel, Canton of Basel-City, Switzerland
Schweizer Paraplegikerzentrum
Nottwil, Canton of Lucerne, Switzerland
Rehaklinik
Valens, Canton of St. Gallen, Switzerland
to assess the tolerability of Uro-Tainer® Polihexanide 0.02%
Change in Visual Analogue Scale (VAS) Score for patients with sustained pain sensation in the bladder Bladder spasms Blood pressure (change in SBP ≥ 40 mmHg is a discontinuation criterion, see 7.4.3) Heart rate Change in tympanic temperature Urine Dipstick (LEU) Occurrence of Flushing Occurrence of Sweating
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
To assess the safety of Uro-Tainer® Polihexanide 0.02% in long-term catheterized patients
Adverse Events * Urticaria * Exanthema * Any other signs and symptoms associated with allergic reactions
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
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