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Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life

  • Urology - Original Paper
  • Published:
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Abstract

Purpose

Intermittent catheterization (IC) is a proven effective long-term bladder management strategy for individuals who have lower urinary tract dysfunction. This study provides clinical evidence about multiple-reuse versus single-use catheterization techniques and if catheter choice can have an impact on health-related quality of life (HRQoL).

Method

A prospective, multi-center, clinical trial studied patients who currently practiced catheter reuse, and who agreed to prospectively evaluate single-use hydrophilic-coated (HC) (i.e. LoFric) catheters for 4 weeks. A validated Intermittent Self-Catheterization Questionnaire (ISC-Q) was used to obtain HRQoL. Reused catheters were collected and studied with regard to microbial and debris contamination.

Results

The study included 39 patients who had practiced IC for a mean of 10 years, 6 times daily. At inclusion, all patients reused catheters for a mean of 21 days (SD = 48) per catheter. 36 patients completed the prospective test period and the mean ISC-Q score increased from 58.0 (SD = 22.6) to 67.2 (SD = 17.7) when patients switched to the single-use HC catheters (p = 0.0101). At the end of the study, 83% (95% CI [67–94%]) preferred to continue using single-use HC catheters. All collected reused catheters (100%) were contaminated by debris and 74% (95% CI [58–87%]) were contaminated by microorganisms, some with biofilm.

Conclusion

Single-use HC catheters improved HRQoL and were preferred over catheter reuse among people practicing IC. Catheter multiple-reuse may pose a potential safety concern due to colonization by microorganisms as well as having reduced acceptance compared to single use.

Trial registry number

ClinicalTrials.gov NCT02129738.

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Acknowledgements

In addition to the authors, the following persons from the clinical study group were essential for the conduct of this study; S Ryan, and L Bossa (Spinal and Rehabilitation Medicine, Prince of Wales Hospital Spinal Unit, Randwick), B Kimmel (Penn Center for Continence and Pelvic Health, Philadelphia) RC O’Connor and H Engelke (Froedtert Medical College and Specialty Clinic, Division of Urology, Milwaukee), RL Clark and P Patterson (North Idaho Urology, Division of Urology, Coeur D’Alene), E Chung and I Oleinikova (Department of Urology, Princess Alexandra Hospital, Brisbane). M Åström (StatCons, Sweden) contributed towards statistical analyses and guidance. Employees of Wellspect, e.g. L Gustafsson, O Sigfridson, L Berggren, N McCormick, G King have all supported in the planning, conduct and reporting of the study.

Funding

The study was funded by Wellspect HealthCare, DENTSPLY IH AB (Sweden).

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Authors and Affiliations

  1. Division of Urology, Department of Surgery, Penn medicine, Perelman School of Medicine, University of Pennsylvania, 3rd Floor West Perelman Bldg, 34th and Civic Center Blvd, Philadelphia, PA, 19104, USA

    Diane K. Newman

  2. Epworth-Monash Rehabilitation Medicine Unit, Monash University, Melbourne, VIC, Australia

    Peter W. New

  3. Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia

    Peter W. New

  4. Department of Rehabilitation, Spinal Rehabilitation Service, Caulfield Hospital, Alfred Health, 260 Kooyong Rd, Caulfield, VIC, 3162, Australia

    Peter W. New

  5. Spinal Injury Rehabilitation Unit, Royal Rehab, 235 Morrison Rd, Ryde, NSW, 2112, Australia

    Roxana Heriseanu

  6. Division of Material and Production, Department of Chemistry, Bioscience and Textile, RISE Research Institutes of Sweden, Box 857, 50115, Borås, Sweden

    Sarunas Petronis & Joakim Håkansson

  7. Wellspect, 43121, Molndal, Sweden

    Maria Å. Håkansson

  8. Spinal and Rehabilitation Medicine, Prince of Wales Hospital Spinal Unit, Barker St., Randwick, NSW, 2031, Australia

    Bonsan Bonne Lee

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  1. Diane K. Newman
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Correspondence to Diane K. Newman.

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Newman, D.K., New, P.W., Heriseanu, R. et al. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol 52, 1443–1451 (2020). https://doi.org/10.1007/s11255-020-02435-9

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  • DOI: https://doi.org/10.1007/s11255-020-02435-9

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