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

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

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.

Study Overview

• Status: Terminated
• Conditions: Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)
• Intervention / Treatment: Device: Uro-Tainer Polihexanide 0.02%

Detailed Description

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
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis
• Germany
  • Beelitz Heilstätten, Germany, 14547
    • Kliniken-Beelitz GmbH
• Switzerland
  • BS
    • Basel, BS, Switzerland, 4056
      • Schweizerisches Paraplegikerzentrum
  • LU
    • Nottwil, LU, Switzerland, 6207
      • Schweizer Paraplegikerzentrum
  • SG
    • Valens, SG, Switzerland, 7317
      • Rehaklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: B. Braun Ltd. Centre of Excellence Infection Control
• Investigators: Principal Investigator: Jürgen Pannek, Prof., Schweizer Paraplegikerzentrum Nottwil

Publications and helpful links

General Publications

• Pannek J, Everaert K, Mohr S, Vance W, Van der Aa F, Kesselring J. Tolerability and safety of urotainer(R) polihexanide 0.02% in catheterized patients: a prospective cohort study. BMC Urol. 2020 Jul 8;20(1):92. doi: 10.1186/s12894-020-00650-1.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: May 9, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants; Polihexanide
• Other Study ID Numbers: OPM-G-H-1101; Cl V-1 3-03-010344 (Other Identifier: EUDAMED)