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

NCT02157415 | Terminated

• 2 other identifiers: OPM-G-H-1101Cl V-1 3-03-010344
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the safety of Uro-Tainer® Polihexanide 0.02% in long-term catheterized patients

  Day 1, Day 2, Day 3, Day 4, Day 5

Study Arms (1)

Long-term catherized patients

EXPERIMENTAL

Uro-Tainer Polihexanide 0.02% 100ml rinsing solution

Device: Uro-Tainer Polihexanide 0.02%

Interventions

Uro-Tainer Polihexanide 0.02% 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.

Long-term catherized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• B. Braun Ltd. Centre of Excellence Infection Control: lead

Study Sites (5)

Universitair Ziekenhuis

Ghent, 9000, Belgium

Location

Kliniken-Beelitz GmbH

Beelitz-Heilstätten, 14547, Germany

Location

Schweizerisches Paraplegikerzentrum

Basel, Canton of Basel-City, 4056, Switzerland

Location

Schweizer Paraplegikerzentrum

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Rehaklinik

Valens, Canton of St. Gallen, 7317, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32641131 DERIVED

Study Officials

• Jürgen Pannek, Prof.

  Schweizer Paraplegikerzentrum Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: June 6, 2014
• Study Start: August 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

BE (1); CH (3); DE (1)