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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Cohort Study on the Tolerability and Safety of Uro-Tainer® Polihexanide 0.02% in Long-term Indwelling Catheterized Patients.

Conditions
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Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)

Intervention / Treatment
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* Device: Uro-Tainer Polihexanide 0.02%


Participation Criteria
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Eligibility Criteria
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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, antihistamines, medications susceptible to cause an autonomic response or to mask an allergic reaction. For the first five patients: impaired pain sensation in the bladder for the first five patients: Administration of any antipyretics and analgesic.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term catherized patients<br>Uro-Tainer Polihexanide 0.02% 100ml rinsing solution | Device: Uro-Tainer Polihexanide 0.02%<br>* Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a maximum of 5 instillations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1, Day 2, Day 3, Day 4, Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1, Day 2, Day 3, Day 4, Day 5 |