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Outcome comparison of catheter model and technique
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Date: 02/03/2022 Requestor: Nicola s47F - personal priv Endorsed by: Charika [[s47F - personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/)](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) Researcher: Aaron s47F - personal privacy Cleared by: Aaron s47F - personal privacy
- Contents
Outcome comparison of catheter model and technique ……………………………………………………. 1
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Contents ……………………………………………………………………………………………………….. 1
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Summary ………………………………………………………………………………………………………. 2
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Catheter types and methods …………………………………………………………………………….. 2
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Outcomes ……………………………………………………………………………………………………… 3
4.1 Risk of urinary tract infections ………………………………………………………………………… 4
4.2 Other adverse events …………………………………………………………………………………… 5
4.3 User preference …………………………………………………………………………………………… 5
- Cost-effectiveness ………………………………………………………………………………………….. 5
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References ……………………………………………………………………………………………………. 7
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Summary
Different catheter types and different methods of use, cleaning and management may affect the comfort, usability and potential risks of catheter use. Due to inconsistency in the literature, firm conclusions are not possible regarding the effect of different catheter types or methods on risk of UTI and other health complications. No conclusions can be drawn to suggest hydrophilic catheters, closed system catheter sets, or ‘no touch’ catheters lower risk of health complications.
Catheter types and management strategies can vary widely in cost. Reusable non-coated catheters are the least expensive catheter type by unit cost. The most expensive is likely single-use, closed-system, hydrophilic catheters. However, when associated costs such as health-care and employment are included, the overall costs may be different.
Most cost-effectiveness studies from the last 7 years find that hydrophilic catheters are more cost-effective over a lifetime compared to single-use uncoated catheters. An Australian study calculates a lifetime saving of $298,450 in favour of hydrophilic catheters. All cost- effectiveness analyses reviewed are limited by assumptions and inferences that may not be supported by current evidence. Therefore, it is not possible to say with confidence that the hydrophilic catheter is more cost-effective than lower cost options.
Risk of urinary tract infection (UTI) and associated health-care costs are a key feature of cost- effectiveness analyses. Most cost-effectiveness studies fix an incidence rate for UTI for different types of catheter. The studies finding that hydrophilic catheters are more cost- effective generally infer a reduced risk of UTI for hydrophilic compared to other types of catheter. However, this conclusion may not be supported by current evidence.
While there are a number of reviews and meta-analyses which favour hydrophilic catheters for reducing risk of UTI and other health complications, the evidence is not firm. Several studies find no difference between catheter types. There is moderate level evidence that hydrophilic catheters may even increase the risk of urethral trauma.
There are also some notable limitations in the literature. There is significant heterogeneity especially around the definition of UTI. Studies are often not generalisable due to non- representative samples and attrition bias.
- Catheter types and methods
In-dwelling catheterisation involves leaving the catheter in place for a period of time. This is not the preferred option for most people requiring catheterisation but is still used by around one third of people with a spinal cord injury (Wu et al, 2022). Intermittent catheterisation involves
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inserting and removing a catheter multiple times a day. Catheters used in intermittent catheterisation may be used once and discarded (single-use) or used multiple times (reusable). Reusable catheters may be used for one day or for longer periods. They usually require washing between uses (Wu et al, 2022; Ye et al, 2021; Health Quality Ontario, 2019).
Single-use catheters can be used with either a sterile technique (sterile catheter, gloves, in a sterile environment as far as possible) or a clean technique (clean hands or gloves). Reusable catheters can only be used with a clean technique (Prieto et al, 2021; Ye et al, 2021; Health Quality Ontario, 2019).
Some catheters require the user or carer to add lubricant before insertion. They are referred to as non-coated catheters to distinguish them from hydrophilic-coated catheters which have a polymer coating that acts as a lubricant when it interacts with water. Hydrophilic catheters may also come in sterile packaging with saline solution, which means the user does not need to add water before insertion. These are called pre-activated hydrophilic catheters. Non-coated catheters may also come in a sterile package pre-lubricated. Catheters may be purchased by themselves or with a urine collection bag already attached (Ye et al, 2021; Health Quality Ontario, 2019).
- Outcomes
Research on outcomes associated with catheter use focusses on:
incidence of UTIs other adverse events (like haematuria, urethral trauma, bladder stones etc.) preference or satisfaction with different types or methods.
Most contemporary research focusses on comparisons of different intermittent catheterisation techniques using hydrophilic or non-coated catheters. Despite this being a well-researched area, few firm conclusions are possible. Many systematic reviews and meta-analyses show inconsistent results.
Due to the quantity of research material available, we have prioritised:
evidence published in the last 7 years (2017-2023) review articles and cost-effectiveness studies evidence related to an Australian context where possible.
The following discussion of catheter type and method outcomes is based on 17 systematic reviews conducted between 2017 and 2023.
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4.1 Risk of urinary tract infections
Low level evidence suggests that intermittent catheterisation is associated with fewer UTIs than in-dwelling catheterisation (Wu et al, 2022; Kinnear et al, 2020).
There is significant disagreement in the literature as to whether hydrophilic catheters are associated with lower risk of developing a UTI. Some meta-analyses have found a significantly reduced risk of UTI for people using hydrophilic catheters (Plata et al, 2023; Gauhur et al 2022; Ye et al, 2021; Feng et al, 2020; Rognoni & Taraconi, 2017). However, the results are not straight-forward. Feng et al (2020) found a 54% reduction in frequency of UTI associated with use of hydrophilic catheters. Rognoni & Taraconi (2017) found a lower risk of UTI associated with hydrophilic catheter compared to single-use non-coated catheter. This contrasts with Plata et al (2023), who found a reduction in frequency of UTIs overall, but not if the comparison is limited to single-use hydrophilic versus single-use non-coated. They found a significantly lower risk in adult hydrophilic catheter users but not the paediatric group. Gauhur et al (2022) found hydrophilic catheters are associated with a statistically significant reduction in UTIs only if the sub-group is limited to long term catheter users. When comparing all subjects, there was no significant difference in UTI frequency. Ye et al (2021) found a significant reduction in UTIs for both hydrophilic and gel-lubricated catheters when compared to non-coated catheters, but no significant difference between hydrophilic and pre-lubricated models. There is some low-very low certainty evidence favouring pre-lubricated catheters presented in other reviews (Health Quality Ontario, 2019; Shamout et al, 2017). A report from Health Quality Ontario (2019) did not find significantly different levels of risk in the development of UTI for any catheter type. Prieto et al (2021) note that both higher risk of UTI and lower risk of UTI are possible considering the margin of error.
This inconsistency is reflected in reviews that did not complete a meta-analysis. Shamout et al (2017) found only one out of 6 papers reviewed found a significant reduction in risk of UTI associated with use of hydrophilic catheter. Barken & Vaabengaard (2022) in contrast, found 8 out of 10 studies supported the use of hydrophilic catheters to reduce UTI frequency.
Prieto et al (2021) suggest that the most impactful question regarding risk of UTI is whether risk is affected by single-use or multiple-use catheter practice. The authors found no compelling evidence that single- or multiple-use was associated with different rates of UTI. This is echoed in the Health Quality Ontario report (2019).
Furthermore, there is some emerging evidence that other strategies such as catheter cleaning techniques or education programs for nurses or carers can decrease risk of UTI for long term catheter users (Alex et al, 2022; Mitchell et al, 2021; Shamout et al, 2017). However, evidence is not sufficient to draw a conclusion regarding these interventions (Prieto et al, 2021; Mangal et al, 2021; Sheperd et al, 2017).
Due to inconsistency of results, firm conclusions are not possible regarding the effect of different catheter types or methods on risk of UTI. Some limitations are pervasive in the literature. Reviewers often refer to differences in the definition of UTI to explain the
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inconsistency of results (Plata et al, 2023; Barken & Vaabengaard, 2022; Prieto et al, 2021; Rognoni & Taraconi, 2017). Many studies included in systematic reviews and meta-analyses have disproportionate levels of male participants and high drop-out rates, especially for hydrophilic treatment groups (Plata et al, 2023; Ye et al, 2021; Rognoni & Taraconi, 2017).
4.2 Other adverse events
Prieto et al (2021) found moderate certainty evidence that non-coated catheters slightly reduce the risk of urethral trauma and bleeding compared with hydrophilic catheters. Whereas Feng et al (2020) found a 55% reduction in risk of urethral trauma associated with hydrophilic catheters. Liao et al (2022) found a significant reduction in microscopic haematuria with hydrophilic catheters compared to non-coated catheters, but no statistically significant difference for gross haematuria. Health Quality Ontario (2019) and Plata et al (2023) found a similar result. Rognoni & Taraconi (2017) found a higher, but non-significant risk of haematuria for hydrophilic catheters.
4.3 User preference
Most studies that track user preference favour hydrophilic catheters (Barken & Vaabengaard 2022; Feng et al, 2020; Shamout et al, 2017). Ye et al (2021) found a stronger preference for pre-activated hydrophilic catheters followed by reusable non-coated, non-preactivated hydrophilic, pre-lubricated and single-use non-coated. However the differences between these groups were not significant. Health Quality Ontario (2019) found a stronger preference for pre- lubricated single use catheters. Prieto et al (2021) found no reliable evidence of difference in preference between catheter models.
- Cost-effectiveness
Cost-effectiveness studies have been completed for Australia (Couchman et al, 2022), Japan (Watanabe et al, 2017), Italy (Rognoni & Tarricone, 2017), United Kingdom (Baker et al, 2023), Brazil (Truzzi et al, 2018), Canada (Health Quality Ontario, 2019; Welk et al, 2018) and United States (Hutton et al, 2018). Multiple systematic reviews consider cost-effectiveness of different catheter models or techniques (Barken & Vaabengaard 2022; Prieto et al 2021; Feng et al 2020; Shamout et al, 2017) but only one was found for which cost-effectiveness was the main focus (Xi et al, 2021).
Most cost-effectiveness analyses have focussed on costs and outcomes for people with spinal cord injury (Couchman et al, 2022; Xi et al, 2021; Truzzi et al, 2018; Welk et al, 2018; Watanabe et al, 2017; Rognoni & Tarricone, 2017). Baker et al (2023) included patients with either spinal cord injury or multiple sclerosis. Hutton et al (2018) included patients with indwelling catheters residing in nursing homes. The study from Health Quality Ontario (2019) focussed on participants with chronic urinary retention.
The international studies from Japan, Canada, UK, USA, Brazil and Italy all suggest that the single use hydrophilic catheter is a cost-effective option in their respective contexts. This is
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primarily due to costs of treatment of UTIs and other complications of UTIs. The exception is one study from Ontario, Canada, which found multiple-use non-coated catheters were the most cost-effective option:
Given the marginal differences in total QALYs across catheter types, the lowest-cost intervention—multiple-use noncoated catheters (one per week)—had the highest probability of being cost-effective when compared with multiple-use noncoated (one per day), single-use noncoated, and single-use hydrophilic catheters. Where it may not be feasible for some patients to clean and reuse catheters, single-use noncoated catheters have the highest probability of being cost-effective (Health Quality Ontario, 2019, pp.79- 80).
This conclusion likely differs from most other cost-effectiveness analyses due to:
limited horizon of 5 years compared with lifetime horizon of other studies a very high estimate of the difference in cost between hydrophilic and non-coated
catheters relative to other studies the authors’ assessment that there is a low level of evidence for significantly
different outcomes for hydrophilic, non-coated catheters and for single or multiple-
use catheters.
Regarding the 5 year horizon, the authors justify this based on limited evidence for the long term incidence of complications for different catheter types and lack of data on the associated costs of complications. Other studies either: i) make cost and incidence predictions based on inferences from related data, or ii) assume costs and risk are constant over a lifetime.
Regarding the high cost estimate, the authors based monthly and unit costs on information providers made available online. They calculated a minimum of $800 per month for single use hydrophilic catheters based on a unit cost of $7.02 and a minimum of $135 per month for single use non-coated catheters based on a unit cost of $1.09 (all prices in Canadian dollars). In contrast, the other Canadian based cost-effectiveness analysis set prices at $3.77 hydrophilic catheters and $1.07 for non-coated catheters (Welk et al, 2018). The hydrophilic catheter unit cost is almost double from one study to the next, which is bound to make a significant difference to the final analysis.
It is important to note that all of these international studies are limited in terms of generalisability. Conclusions may not transfer to other contexts or service systems. As with the two Canadian studies, Xi et al (2021) note that the stated difference in costs between hydrophilic and non-hydrophilic catheters varied considerably between the studies they reviewed (from $2.49 USD to $24.24 USD per day). Few of the cost-effectiveness studies reviewed considered other types of catheters, for example, gel-lubricated non-hydrophilic catheters. All these studies also make assumptions inferences or about the benefits of hydrophilic catheters which may not be supported by the current evidence. And most recognise that either important data points are missing or the quality of the included clinical
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evidence is low. As such, its not clear if long term costs of either product are under- or over- estimated.
One study looked at the cost-effectiveness of hydrophilic catheters for people with spinal cord injury in an Australian context. Couchman et al (2022) found hydrophilic catheters have higher unit cost, but ultimately provide a more cost-effective option due to reduction in UTIs, quality of life, life years gained and productivity. Including unit cost and societal costs such as productivity loss, hospital admissions and treatment for UTIs and other complications, the authors calculate a lifetime saving of $298,450 in favour of hydrophilic catheters.
This study has some limitations. The authors were not able to source Australian data on UTI frequency for people with spinal cord injury living in the community or for costs associated with some UTI complications. They inferred a UTI frequency based on in-hospital incidence and clinical judgement. Outcomes for hydrophilic catheters (e.g reduction in UTIs) were based on only meta-analyses which showed a positive effect on UTI frequency in favour of hydrophilic catheters. A few of those meta-analyses were published over 25 years ago. Furthermore, the authors note that a longitudinal cost-effective analysis based on real-world cost and health outcome information would be more reliable.
- References
Alex, J., Maneze, D., Ramjan, L. M., Ferguson, C., Montayre, J., & Salamonson, Y. (2022). Effectiveness of nurse-targeted education interventions on clinical outcomes for patients with indwelling urinary catheters: A systematic review. Nurse education today, 112, 105319. https://doi.org/10.1016/j.nedt.2022.105319
Baker, H., Avey, B., Overbeck Rethmeier, L., Mealing, S., Lynge Buchter, M., Averbeck, M. A., & Thiruchelvam, N. (2023). Cost-effectiveness analysis of hydrophilic-coated catheters in long-term intermittent catheter users in the UK. Current medical research and opinion, 39(2), 319–328. https://doi.org/10.1080/03007995.2022.2151734
Barken, K. B., & Vaabengaard, R. (2022). A scoping review on the impact of hydrophilic versus non-hydrophilic intermittent catheters on UTI, QoL, satisfaction, preference, and other outcomes in neurogenic and non-neurogenic patients suffering from urinary retention. BMC urology, 22(1), 153. https://doi.org/10.1186/s12894-022-01102-8
Feng, D., Cheng, L., Bai, Y., Yang, Y., & Han, P. (2020). Outcomes comparison of hydrophilic and non-hydrophilic catheters for patients with intermittent catheterization: An updated meta-analysis. Asian journal of surgery, 43(5), 633–635. https://doi.org/10.1016/j.asjsur.2019.12.009
Gauhar, V., Castellani, D., Teoh, J. Y., Nedbal, C., Chiacchio, G., Gabrielson, A. T., Heldwein, F. L., Wroclawski, M. L., de la Rosette, J., Donalisio da Silva, R., Galosi, A. B., & Somani, B. K. (2022). Catheter-Associated Urinary Infections and Consequences of Using Coated versus Non-Coated Urethral Catheters-Outcomes of a Systematic
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Review and Meta-Analysis of Randomized Trials. Journal of clinical medicine, 11(15), 4463. https://doi.org/10.3390/jcm11154463
Health Quality Ontario (2019). Intermittent Catheters for Chronic Urinary Retention: A Health Technology Assessment. Ontario health technology assessment series, 19(1), 1–153.
Hutton, D. W., Krein, S. L., Saint, S., Graves, N., Kolli, A., Lynem, R., & Mody, L. (2018). Economic Evaluation of a Catheter-Associated Urinary Tract Infection Prevention Program in Nursing Homes. Journal of the American Geriatrics Society, 66(4), 742–747. https://doi.org/10.1111/jgs.15316
Kinnear, N., Barnett, D., O’Callaghan, M., Horsell, K., Gani, J., & Hennessey, D. (2020). The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Neurourology and urodynamics, 39(2), 854–862. https://doi.org/10.1002/nau.24253
Liao, X., Liu, Y., Liang, S., & Li, K. (2022). Effects of hydrophilic coated catheters on urethral trauma, microtrauma and adverse events with intermittent catheterization in patients with bladder dysfunction: a systematic review and meta-analysis. International urology and nephrology, 54(7), 1461–1470. https://doi.org/10.1007/s11255-022-03172-x
Mangal, S., Pho, A., Arcia, A., & Carter, E. (2021). Patient and Family Engagement in Catheter-Associated Urinary Tract Infection (CAUTI) Prevention: A Systematic Review. Joint Commission journal on quality and patient safety, 47(9), 591–603. https://doi.org/10.1016/j.jcjq.2021.05.009
Mitchell, B., Curryer, C., Holliday, E., Rickard, C. M., & Fasugba, O. (2021). Effectiveness of meatal cleaning in the prevention of catheter-associated urinary tract infections and bacteriuria: an updated systematic review and meta-analysis. BMJ open, 11(6), e046817. https://doi.org/10.1136/bmjopen-2020-046817
Plata, M., Santander, J., Zuluaga, L., Torres-Sandoval, C., Valencia, S., Azuero, J., & Trujillo, C. G. (2023). Hydrophilic versus non-hydrophilic catheters for clean intermittent catheterization: a meta-analysis to determine their capacity in reducing urinary tract infections. World journal of urology, 41(2), 491–499. https://doi.org/10.1007/s00345-022- 04235-5
Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database of Systematic Reviews 2021, Issue 10. Art. No.: CD006008. DOI: 10.1002/14651858.CD006008.pub5. Accessed 27 February 2023
Rognoni, C., & Tarricone, R. (2017a). Intermittent catheterisation with hydrophilic and non- hydrophilic urinary catheters: systematic literature review and meta-analyses. BMC urology, 17(1), 4. https://doi.org/10.1186/s12894-016-0191-1
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Rognoni, C., & Tarricone, R. (2017b). Healthcare resource consumption for intermittent urinary catheterisation: cost-effectiveness of hydrophilic catheters and budget impact analyses. BMJ open, 7(1), e012360. https://doi.org/10.1136/bmjopen-2016-012360
Shamout, S., Biardeau, X., Corcos, J., & Campeau, L. (2017). Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review. Spinal cord, 55(7), 629–643. https://doi.org/10.1038/sc.2016.192
Shepherd AJ, Mackay WG, Hagen S. Washout policies in long-term indwelling urinary catheterisation in adults. Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD004012. DOI: 10.1002/14651858.CD004012.pub5. Accessed 28 February 2023
Truzzi, J. C., Teich, V., & Pepe, C. (2018). Can hydrophilic coated catheters be beneficial for the public healthcare system in Brazil? - A cost-effectiveness analysis in patients with spinal cord injuries. International braz j urol : official journal of the Brazilian Society of Urology, 44(1), 121–131. https://doi.org/10.1590/S1677-5538.IBJU.2017.0221
Xi, M., Elterman, D. S., Welk, B., Pakosh, M., & Chan, B. C. F. (2020). Cost-effectiveness of hydrophilic-coated urinary catheters for individuals with spinal cord injury: A systematic review. BJUI compass, 2(2), 71–81. https://doi.org/10.1002/bco2.63
Watanabe, T., Yamamoto, S., Gotoh, M., Saitoh, T., Yokoyama, O., Murata, T., & Takeda, M. (2017). Cost-Effectiveness Analysis of Long-Term Intermittent Self-Catheterization with Hydrophilic-Coated and Uncoated Catheters in Patients with Spinal Cord Injury in Japan. Lower urinary tract symptoms, 9(3), 142–150. https://doi.org/10.1111/luts.12122
Welk, B., Isaranuwatchai, W., Krassioukov, A., Husted Torp, L., & Elterman, D. (2018). Cost- effectiveness of hydrophilic-coated intermittent catheters compared with uncoated catheters in Canada: a public payer perspective. Journal of medical economics, 21(7), 639–648. https://doi.org/10.1080/13696998.2018.1443112
Wu, S. Y., Jhang, J. F., Liu, H. H., Chen, J. T., Li, J. R., Chiu, B., Chen, S. L., & Kuo, H. C. (2022). Long-Term Surveillance and Management of Urological Complications in Chronic Spinal Cord-Injured Patients. Journal of clinical medicine, 11(24), 7307. https://doi.org/10.3390/jcm11247307
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