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

NCT ID: NCT02157415

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-07-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Long-term catherized patients

Uro-Tainer Polihexanide 0.02% 100ml rinsing solution

Group Type: EXPERIMENTAL

Uro-Tainer Polihexanide 0.02%

Intervention Type: DEVICE

Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a maximum of 5 instillations.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Ltd. Centre of Excellence Infection Control

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jürgen Pannek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Schweizer Paraplegikerzentrum Nottwil

Locations

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

Countries

Belgium; Germany; Switzerland

References

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.

Reference Type: DERIVED

PMID: 32641131 (View on PubMed)

Other Identifiers

Cl V-1 3-03-010344

Identifier Type: OTHER

Identifier Source: secondary_id

OPM-G-H-1101

Identifier Type: -

Identifier Source: org_study_id