Teleflex summary of third party study

BLADDER MANAGEMENT Clinical Summary Teleflex summary of third party study: Prospective multicentre observational study assessing the tolerance and perception of patients using the Liquick Base catheter with an Ergothan tip Gamé X, Gania L, Perrouin-Verbe B, et al.

The Liquick Base intermittent catheter with tapered Ergothan tip did not appear to cause urethral trauma in patients with neurogenic bladder-sphincter dysfunctions. Adherence rates for the Liquick Base intermittent catheter with Ergothan tip were over 90% after 3 and 6 months.

Objective The aim of this study was to assess tolerance and patient perception of the single-use Liquick Base intermittent catheter with Ergothan tip (a hydrophilic self-lubricated catheter designed for intermittent self-catheterisation) in patients with neurogenic bladder-sphincter dysfunctions. Methods This was a prospective multi-center observational study in 42 patients in 14 centres in France. Eligible patients: • Were aged over 18 years with neurogenic pathology • Had no prior experience of performing intermittent self-catherization • Had a medical indication warranting intermittent self-catheterisation • Were willing to perform self-catheterisation Patients were reviewed at three time points: at the start of the study, at 3 months and at 6 months. • At enrolment, sociodemographic data and data on the neurogenic pathology requiring intermittent catheterisation and the treatments for bladder-sphincter dysfunctions were collected. • At 3- and 6-month review: – Data were collected about the onset of any complications or problems linked to managing the lower urinary tract, the stability of the neurogenic condition, the continuation of any treatment for an overactive bladder or detrusor muscle, and whether the patient was still using the Liquick Base intermittent catheter. – The patient completed a questionnaire that asked if any bleeding had occurred, if it had been difficult to insert the catheter, if it had been impossible to self-catheterize, and whether there had been any urinary infections or bladder infections. – A Visual Analog Scale was used to evaluate the patients’ experience of using the catheter. • Statistical analysis was carried out as an observational and descriptive analysis. Results In total, 40 of 42 enrolled patients were assessed (two patients were excluded for not meeting participation requirements). • Overall, 30 of the 40 (75%) patients were male with a mean age of 50.1±14.9 years. • The most common neurogenic pathology reported was spinal cord injury (21/40; 52.5%) followed by multiple sclerosis (8/40; 20%); the remaining 11 patients (27.5%) had an alternative cause.1 At six months, complete information was only available for 20 patients. • The median duration of the neurogenic pathology was 1 year. There were no cases of false passage or urethral trauma during the study period. • Urethral bleeding occurred mainly in the early stages of catheterisation with bleeding events occurring at least once in 10 (25%) patients in the first three months and in 3 of 20 (15%) patients between 3 and 6 months. • At least one urinary infection episode was reported in 9 (22.5%) patients in the first three months and in 2 (10.5%) patients between 3 and 6 months. In total, two (5%) patients in the first three months and 4 (10%) patients between 3 and 6 months sought medical attention for complications. Difficulty inserting the catheter and failure to insert the catheter were reported in 10 (25%) patients and 7 (17.5%) patients, respectively, in the first three months and in 2 (10%) patients (each category) between 3 and 6 months. After 3 and 6 months, 90% of patients were still using the Liquick Base intermittent catheter. Patients reported that the Liquick Base catheter and its packaging were generally easy to use (Fig. 1 and Fig. 2). 1 Alternate causes included: peripheral denervation of the bladder, radiculitis, peripheral neuropathy, spina bifida and myelomeningocele, Devic’s disease, hemiparesis of undetermined origin, Lewy body disease, neurolymphoma, cerebral palsy, undetermined neurogenic disease, encephalitis

Visual Analog Scale (0 [very difficult / totally useless] and 10 [very easy/very useful]) Visual Analog Scale (0 [very difficult / totally useless] and 10 [very easy/very useful]) 8 8 9 9 10 10 7 7 6 6 5 5 4 4 3 3 2 2 1 1 0 0 Was the packaging easy to open? Was the packaging easy to open? Was the sachet easy to open? Was the sachet easy to open? Was the ability to hang the packaging up useful? Was the ability to hang the packaging up useful? Was the sleeve useful for not touching the catheter? Was the sleeve useful for not touching the catheter? Was it easy to see the self-catheterisation process thanks to the colored tip? Was it easy to see the self-catheterisation process thanks to the colored tip? Was it easy to insert the catheter? Was it easy to insert the catheter? Was the packaging easy to hang up? Was the packaging easy to hang up? Figure 1. Visual Analog Scale assessment of patient perception at 3 months Figure 2. Visual analog scale assessment of patient perception at 6 months 8.9 (0–10) 9.0 (6.5–10) Median (range) VAS score Median (range) VAS score 9.35 (0–10) 8.7 (2.6–9.9) 9.05 (2.6–10) 8.95 (5.2–10) 8.5 (0–10) 8.45 (0–10) 9.2 (0–10) 9.2 (0–10) 8.9 (0–10) 8.7 (0.3–10) 8.75 (0–10) 9.0 (0–10)

Ergothan tip

Teleflex Headquarters International, Ireland Teleflex Medical Europe Ltd., IDA Business and Technology Park, Dublin Road, Athlone, Co Westmeath, Ireland Phone +353 (0)9 06 46 08 00 · Fax +353 (0)14 37 07 73 orders.intl@teleflex.com · www.teleflex.com www.teleflexurology.com Teleflex, the Teleflex logo and Liquick are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/ or other countries. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. © 2022 Teleflex Incorporated. All rights reserved. MCI-2021-0665 · REV 0 · 06 22 PDF

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