Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)NCT02157415
Prospective Cohort Study on Tolerability & Safety of Uro-Tainer® Polihexanide 0.02%
A study testing Uro-Tainer Polihexanide 0.02% in people with Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic), run by B. Braun Ltd. Centre of Excellence Infection Control at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)
- What is being tested?
- Uro-Tainer Polihexanide 0.02%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2013to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Switzerland3 sites
Schweizerisches Paraplegikerzentrum
Basel, Canton of Basel-City, 4056
Schweizer Paraplegikerzentrum
Nottwil, Canton of Lucerne, 6207
Rehaklinik
Valens, Canton of St. Gallen, 7317
About this study
Official title: 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.
Read the 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.
- Being tested
- Uro-Tainer Polihexanide 0.02%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Long-term catherized patients | Experimental | Uro-Tainer Polihexanide 0.02% 100ml rinsing solution Receives: Device: Uro-Tainer Polihexanide 0.02% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Adverse Events
- Urticaria
- Exanthema
- Any other signs and symptoms associated with allergic reactions
Measured: Day 1, Day 2, Day 3, Day 4, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: After consultation with a medical expert the Notified Body confirmed premature termination of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jürgen Pannek, Prof., Principal investigator, Schweizer Paraplegikerzentrum Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157415
- Sponsor's protocol ID
- OPM-G-H-1101
- Other IDs
- Cl V-1 3-03-010344
- Status last verified
- Jul 2018
- First submitted
- 9 May 2014
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32641131
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Tolerability and Safety of Uro-Tainer® Polihexanide 0.02% in Long-term Indwelling Catheterized Patients.
- ClinicalTrials.gov ID
- NCT02157415
- Acronym / sponsor ID
- OPM-G-H-1101
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After consultation with a medical expert the Notified Body confirmed premature termination of the study.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection ControlIndustry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term catherized patients | Experimental | Device: Uro-Tainer Polihexanide 0.02%Uro-Tainer Polihexanide 0.02% 100ml rinsing solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Long-term catherized patients |
Primary outcome
to assess the tolerability of Uro-Tainer® Polihexanide 0.02%
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
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
1 secondary outcome
To assess the safety of Uro-Tainer® Polihexanide 0.02% in long-term catheterized patients
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
Results and safety
The study was stopped early (reason given: After consultation with a medical expert the Notified Body confirmed premature termination of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 32641131Pannek 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.
Related trials for Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)
Active, not recruitingPhase 2
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Neurogenic Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Pannek, Prof. principal investigator
Schweizer Paraplegikerzentrum Nottwil
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uro-Tainer Polihexanide 0.02% in people with Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic), run by B. Braun Ltd. Centre of Excellence Infection Control at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After consultation with a medical expert the Notified Body confirmed premature termination of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the tolerability of Uro-Tainer® Polihexanide 0.02% (time frame: Day 1, Day 2, Day 3, Day 4, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.