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Intermittent urinary catheterization

Urinary tract infection - a common burden

Urinary tract infection (UTI) is one of the most important complication of patients requiring intermittent urinary catheterization[1, 2] and can impact patients' overall health and quality of life.[1, 3]

The emotional and practical burden of intermittent catheterization and UTIs is considerable in the patients’ lives.[3] UTIs account for about 23 to 63 percent of the total lifetime costs for spinal cord injury patients practicing intermittent catheterization.[4] Very important are good education of all involved in IC, good patient compliance, the use of proper material and the application of a good catheterization technique.[2]

UTIs related to intermittent catheterization can have negative consequences such as:

  • High morbidity and frequent hospitalizations[4]
  • Risk of developing dangerous resistance to antibiotics[2]
  • Economic burden[4] for the healthcare system

Recurrent urinary tract infections often lead to repeated use of antibiotics and thus can accelerate the development of antibiotic resistance and persistence.[5]

It is therefore very important to reduce the risks of UTIs in patients as much as possible.

Real-World Evidence

Research into ssUTIs in users of intermittent urinary catheters

We funded the first real-world evidence of intermittent catheterization to compare the effects of pre-lubricated and hydrophilic catheters on the incidence of symptoms suggestive of urinary tract infections (ssUTIs).[6]

A patient database compiled by a representative panel of 1,950 general practitioners and 2,950,381 active patients in the UK was used for this longitudinal, observational study. This database considered 5,296 people using catheters.

Outcome of the study

Most importantly, the study showed significant results indicating a lower incidence of ssUTIs when pre-lubricated catheters were used:[6]
 

  • The number of ssUTIs per affected patient was significantly lower when pre-lubricated instead of hydrophilic catheters were used in the groups of female users and in the subgroup of 18 to 50 years.
  • The proportion of patients with one or more ssUTIs in the study period was lower when pre-lubricated catheters instead of hydrophilic catheters were used.
  • The proportion within the "continuous use" subgroup (subgroup of patients who did not switch between catheter types during the study) who had at least one ssUTI was significantly lower when pre-lubricated instead of hydrophilic catheters were used.
An infographic from B. Braun titled 'Real-World-Evidence Research: Symptoms Suggestive of Urinary Tract Infections (ssUTI). Study design and extract of its outcome, modified by B. Braun for the EAU congress 2021.

Authors and acceptance of the study

Professor Chapple (Royal Hallamshire Hospital, Department of Urology, Sheffield, United Kingdom), Professor Chartier Kastler (Sorbonne University, Department of Urology, Paris, France) and Professor Schurch (Vaudois University Hospital of Lausanne, Department of Clinical Neurosciences, Lausanne, Switzerland) participated in and supported this study which was accepted by three different congresses:
 

  • European Association of Urology (EAU) 8 -12 July 2021; Author: Prof. Emmanuel Chartier-Kastler
  • ISCoS, Canada, Vancouver, 29 Sept -2 Oct 2021; Author: Prof. Emmanuel Chartier-Kastler
  • ICS, Australia, Melbourne, 14 -17 Oct 2021; Author: Prof. Emmanuel Chartier-Kastler; Speaker: Prof. Chapple

Related documents

Definitions of Real-World Evidence (RWE) and Real-World Data (RWD)

Broadly, all data collected routinely (that is, not as a part of randomized controlled trials) on patient health from different sources, are called RWD7.

The US FDA defines Real-World Data as data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include7:
 

  • Data derived from electronic health records (EHRs), claims and billing data
  • Data from product and disease registries
  • Patient-generated data including in home-use settings
  • Data gathered from other sources that can inform on health status, such as mobile devices

Real-World Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data (RWD)[7].

References

  1. Öztürk R, Murt A. Epidemiology of urological infections: a global burden. World J Urol. 2020 Nov;38(11):2669-2679. doi: 10.1007/s00345-019-03071-4. Epub 2020 Jan 10. PMID: 31925549.
  2. Wyndaele JJ. Complications of intermittent catheterization: their prevention and treatment. Spinal Cord. 2002 Oct;40(10):536-41. doi: 10.1038/sj.sc.3101348. PMID: 12235537
  3. Fumincelli L, Mazzo A, Martins JCA, Henriques FMD, Cardoso D, Rodrigues MA. Quality of Life of Intermittent Urinary Catheterization Users and Their Caregivers: A Scoping Review. Worldviews Evid Based Nurs. 2017 Aug;14(4):324-333. doi: 10.1111/wvn.12231. PMID: 28742287.7.
  4. Rognoni C, Tarricone R. Healthcare resource consumption for intermittent urinary catheterisation: cost-effectiveness of hydrophilic catheters and budget impact analyses. BMJ Open. 2017 Jan 17;7(1):e012360. doi: 10.1136/bmjopen-2016-012360. PMID: 28096251; PMCID: PMC5253566. 
  5. Huemer M, Mairpady Shambat S, Brugger SD, Zinkernagel AS. Antibiotic resistance and persistence-Implications for human health and treatment perspectives. EMBO Rep. 2020 Dec 3;21(12):e51034. doi: 10.15252/embr.202051034. Epub 2020 Dec 8. PMID: 33400359; PMCID: PMC7726816.
  6. Chartier-Kastler E, Chapple C, Schurch B, Saad M. A Real-world data analysis of intermittent catheterization, showing the impact of prelubricated versus hydrophilic catheter use on the occurrence of symptoms suggestive of urinary tract infections. Eur Urol Open Sci. 2022 Mar 4;38:79-87. doi: 10.1016/j.euros.2022.02.008. PMID: 35495281; PMCID: PMC9051966.
  7. Dang A. Real-World Evidence: A Primer. Pharmaceut Med. 2023 Jan;37(1):25-36. doi: 10.1007/s40290-022-00456-6. Epub 2023 Jan 5. PMID: 36604368; PMCID: PMC9815890.

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