Intermittent catheter choice impacts quality of life: Clinical study on safety and preference of single vs. reuse catheters.

Newman D K1, O'Connor R C2, Clark R3, Heriseanu R4, Chung E5, New P6, Lee B7

Research Type

Clinical

Abstract Category

Continence Care Products / Devices / Technologies

Abstract 199
Products
Scientific Podium Short Oral Session 9
Wednesday 29th August 2018
14:12 - 14:20
Hall B
Clinical Trial Infection, Urinary Tract Prospective Study
1. University of Pennsylvania, 2. Medical College and Specialty Clinic, 3. North Idaho Urology, 4. Spinal Injury Rehabilitation Unit, 5. University of Queensland, 6. Clinical Lead Spinal Rehabilitation Unit, Department of Rehabilitation, 7. Spinal and Rehabilitation Medicine, Prince of Wales Hospital
Presenter
D

Diane K Newman

Links

Abstract

Hypothesis / aims of study
Intermittent catheterization (IC) is common bladder management for individuals with Spinal Cord Injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD). At present, there is an ongoing debate whether catheter reuse is as safe as single-use catheterization as there is a general lack of clinical evidence [1]. The aims of this study were to explore real life patient-related clinical data on safety and satisfaction of reuse vs. single-use catheters for IC in male and female patients.
Study design, materials and methods
This was a prospective, multi-center, clinical trial conducted in the United States and in Australia. Sample size was set to 20 patients per country, considering comparisons of proportions between reuse vs. single-use catheters of approximately 60% vs. 10% (90% power, 5% 2-sided level of significance). The target population comprised people who currently practiced catheter reuse, and who agreed to prospectively evaluate single-use hydrophilic-coated (HC) catheters for 4 weeks. Participants reported outcomes which included the Intermittent Self-Catheterization Questionnaire (ISC-Q) to study patient satisfaction and health-related quality of life (HRQoL) [2]. Safety measures included bacteria contamination of reused catheters (detected by culturing and/or scanning electron microscope (SEM)) and patient-reported urological complications.
Results
The study cohort consisted of 39 patients (Australia n = 18, United States n = 21). The mean age was 55 (SD = 13) years and the male/female distribution 69%/31%. All patients practiced IC due to non-neurogenic (n=13) or NLUTD (n=26). The majority (79%) had normal hand function and had practiced IC for a mean time of 10 years (SD = 9). All practiced self-catheterization with a mean of 6 times daily (SD = 2). Urethral sensitivity was normal in 31%, reduced in 38%, and lacking in 31%. At inclusion, all patients reused catheters for a mean of 21 days (SD = 48) per catheter. Reused catheter types were plastic (e.g. vinyl or PVC) 44%, red rubber (latex) 10%, and silicone 46%. Lubricants were used by 85%. Catheter cleaning was practiced by 92%; soap and water (44%) or running water (44%) were mainly used as cleaning methods.  
A total of 36 patients completed the prospective test period and the mean ISC-Q score increased from 58.00 (SD = 22.57) to 67.19 (SD = 17.70) when patients switched to the single-use HC catheters (Figure 1). This corresponds to a statistically significant change of 9.42 (SD = 22.29) units (p = 0.0101) and a 20% increase in HRQoL. Higher scores were reported for the single-use HC catheters for all ISC-Q domains, i.e. better ‘ease of use’, ‘convenience’, ‘discreetness’, and ‘psychological’ were reported for single-use HC (Figure 2). Additional patient reported outcomes, specifying catheter satisfaction and comfort, also revealed significant differences in favor of single-use HC catheters when compared to reuse catheters. For example, fewer patients reported discomfort or pain with the single-use HC as compared to the reuse catheter (33% vs. 44%, p-value 0.0192). More patients reported that they were satisfied or very satisfied with the single-use HC as compared to the reuse catheter (83% vs, 54%, p-value = 0.0241). 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 (e.g. urine residuals). In 29 out of the 39 (74%) (95%CI [58%, 87%]) collected reused catheters, bacteria contamination was verified by either culturing or SEM. The most common detected species were Staphylococcus, Enterococcus, Pseudomonas, and Klebsiella. No bacteria contamination was detected in the single-use HC catheters (i.e. control group). 
At the start of the study, 64% (n = 25) of the patients reported to have experienced urological complications in the last 12 months, mainly urinary tract infections (UTI). During the prospective test period, 75% (n = 27) were free from urological complications (p = 0.0007, Binomial test).
Interpretation of results
Results show a strong preference for IC with single-use HC catheters when compared to catheter reuse. Single-use HC catheters were also associated with a higher health-related QoL. Catheter reuse pose a potential patient safety issue as high levels of bacteria and debris contamination were detected on the collected reused catheters. Based on these results, clinicians should prescribe single-use IC and HC catheters should be the first and standard choice for catheter type.
Concluding message
Single-use HC catheters improved QoL and were preferred over catheter reuse among people practicing IC. Catheter reuse may pose a potential patient safety concern through biofilm colonization as well as reducing IC acceptance by people with NLUTD.
Figure 1
Figure 2
References
  1. Christison K, Walter M, Wyndaele JJM, Kennelly M, Kessler TM, Noonan VK, Fallah N, Krassioukov AV. Intermittent catheterization: The devil is in the details. J Neurotrauma. 2017 Nov 6. doi: 10.1089/neu.2017.5413.
  2. Pinder B, Lloyd AJ, Elwick H, Denys P, Marley J, Bonniaud V. Development and psychometric validation of the Intermittent Self-Catheterization Questionnaire. Clin Ther 2012;34(12):2302-2313
Disclosures
<span class="text-strong">Funding</span> The study was funded by Wellspect HealthCare, DENTSPLY IH AB (Sweden) <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Registration Number</span> The clinical study is registered in clinicaltrial.gov with the identifier NCT02129738 <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Approved by: University of Pennsylvania IRB (#820448), Medical College of Wisconsin/Froedtert Hospital IRB (PRO00022345) and Western IRB (PRO No 20140762), South Eastern Sydney Local Health District (HREC ref no 14/113), Metro South Hospital and Health Service (HREC/15/QPAH/819) and The Alfred Hospital Ethics Committee (271/14) <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes