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

B. Braun

Status

Terminated

Conditions

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

Treatments

Device: Uro-Tainer Polihexanide 0.02%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02157415

OPM-G-H-1101

Cl V-1 3-03-010344 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.