Background: Intermittent catheterization (IC), the preferred procedure to manage lower urinary tract dysfunction, increases the risk for urinary tract infection (UTI) and negatively impacts quality of life (QoL).1-4 Hydrophilic intermittent catheters (ICs) with a tip and sleeve allow for insertion without touch contamination and are hypothesized to reduce UTI risks and improve QoL by preventing touch contamination of the catheter surface.5

Objectives: This statistical analysis aimed to compare UTI rates and QoL (as measured by the Intermittent Self-Catheterization Questionnaire [ISC-Q]) between hydrophilic ICs with a protective tip and sleeve and a collection bag (Group A) to similar ICs without a protective sleeve (Group B) .6

Design: Data was sourced from ConCaReTM continence care registry, a multinational, longitudinal observational study.7

Methods: 218 visits from 32 subjects (26 with spinal cord injury) using ICs from Groups A and B were included. UTIs were diagnosed by healthcare providers and ISC-Q responses were self-reported. Generalized linear mixed models compared UTI odds and ISC-Q scores between the two groups.8-13

Results: Subjects who used ICs from Group A demonstrated a statistically significant 62.3% lower odds of UTI compared to Group B (p<0.05). Furthermore, total ISC-Q scores for Group A were significantly greater than Group B (a difference of 8.85 points; p<0.05), and this difference exceeded the ISC-Q minimum important difference range, which may indicate a clinically relevant difference in QoL.14,15

Subjects who used ICs from Group A (sleeved ICs) were at a lower risk of UTIs and had a greater QoL compared to subjects who used ICs from Group B (non-sleeved ICs).

Conclusions: Subjects who used hydrophilic ICs with a protective tip and sleeve and a collection bag (Group A) demonstrated a significantly lower UTI risk and greater QoL compared to subjects who used ICs without protective sleeves. These findings may support the use of ICs with protective sleeves for patients requiring IC.



Full list of References:
1. Non-surgical urologic management of neurogenic bladder after spinal cord injury. Romo, P.G.B, et al.
36, 2018, World Journal Urology, pp. 1555-1568.

2. Identifying the risk factors for catheter-associated urinary tract infections: a large cross-sectional study of six hospitals. AS, Leticia-Kriegel, et al. 2019, BMJ, p. 9:e022137.

3. The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Kinnear, N, et al. 39, 2020, Neurology and Urodynamics, pp. 854-862.

4. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Newman, D.K., et al. 52, 2020, International Urology Nephrology, pp. 1443-
1451.

5. Hollister Incorporated. 100% No Touch Protection. [Online] 2023. https://www.hollister.com/en/continencecare/vapro.

6. Development and psychometric validation of the intermittent self-catheterization questionnaire. Binny Pinder, Andrew J Lloyd, Hannah Elwick, Pierre Denys, Jerome Marley, Véronique Bonniaud. 2012, Clinical Therapeutics, pp. 2302-2313.

7. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical
Records. Kim, H. S., Lee, S., & Kim, J. H. 34, 2018, Journal of Korean medical science, Vol. 33, p. e213.

8. SAS Institute Inc. SAS/STAT® 13.1 User’s Guide The GLIMMIX Procedure. [Online] 2013.
https://documentation.sas.com/doc/en/pgmsascdc/9.4_3.3/statug/statug_glimmix_overview01.htm#:~
:text=empirical%20(sandwich)%20estimators%20to%20make%20analysis%20robust%20against%20miss pecification%20of%20the%20covariance%20structure%20and%20to%20adjust%20.

9. SAS/STAT® 13.1 User’s Guide. Cary, NC: SAS Institute Inc. SAS Institute Inc. 2013, Vol. The GLIMMIX Procedure.

10. Agresti, Alan. Categorical Data Analysis; Third Edition. 2013.

11. Cranberries for preventing urinary tract infections. Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM 2023, Cochrance Database Syst Rev., Vol. 4.

12. Urinary tract infection in older adults. Rowe, T. A., & Juthani-Mehta, M. 5, 2013, Aging health, Vol.
9.

13. A simulation study of the number of events per variable in logistic regression analysis. Peduzzi, Peter, et al. 12, 1996, Journal of Clinical Epidemiology, Vol. 49, pp. 1373-1379.

14. Hollister Data on File, ref-03663, 2023

15. Hollister Data on File, ref-03664, 2023

Non-surgical urologic management of neurogenic bladder after spinal cord injury. Romo, P.G.B, et al. 36, 2018, World Journal Urology, pp. 1555-1568.
Identifying the risk factors for catheter-associated urinary tract infections: a large cross-sectional study of six hospitals. AS, Leticia-Kriegel, et al. 2019, BMJ, p. 9:e022137.
The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Kinnear, N, et al. 39, 2020, Neurology and Urodynamics, pp. 854-862.