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  • Title: Quantification of User and Manufacturer Variabilities in Urinary Catheter Anchoring Balloon Inflation and Mitigation of Variability by Flow Resistance.
    Author: Davis NF, Cunnane EM, Mooney RC, Manecksha RP, Thornhill JA, Walsh MT.
    Journal: Urology; 2017 Apr; 102():258-263. PubMed ID: 28094045.
    Abstract:
    OBJECTIVE: To quantify user variability and manufacturer variability in urinary catheter anchoring balloon inflation pressure and to mitigate any significant variance by incorporating flow resistance into the anchoring balloon inflation process. METHODS: Inflation of a urinary catheter anchoring balloon was performed at atmospheric pressure by different users (n = 8) to investigate user variability. A calibrated pressure transducer measured inflation pressures, and a video extensometer measured balloon inflation profiles. Manufacturer variability was investigated by applying constant forces to the plunger of conventional syringes to mimic "heavy-," "intermediate-," and "light"-handed users for 3 brands of catheter. Flow restrictors of variable reduced cross-sectional areas were introduced to the outflow of the inflation syringes to investigate the effect of flow resistance on anchoring balloon inflation profiles. RESULTS: Variations in maximum inflation pressures (range: 75-355 kPa) were observed among the different users. There were no significant differences in maximum inflation pressure between brands at any of the 3 simulated hand forces (P = .97). Increasing the flow resistance significantly reduces the applicable inflation pressure of all hand forces (P < .001). Specifically, the difference in inflation pressure between heavy- and light-handed forces is reduced from over 405 kPa to under 65 kPa. Introducing flow resistance does not result in a significant difference in inflation pressure between brands (P = .254). CONCLUSION: There is significant user variability in urinary catheter balloon inflation pressure. This variation can be significantly reduced by introducing flow resistance to the inflation technique.
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