Single-blind, Randomised, Parallel Group Study of the Bard Biocath Catheter and a Silicone Elastomer Coated Catheter

Authors

  • E. BULL RMN, RGN, DNCert PWT,

    1. Department of Urology, Derbyshire Royal Infirmary, Derby
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      E. Bull, RMN, RGN, DNCert, PWT, Community Charge Nurse, South Derbyshire Community Health District.

  • C. P. CHILTON FRCS,

    Corresponding author
    1. Department of Urology, Derbyshire Royal Infirmary, Derby
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      C. P. Chilton, FRCS, Consultant Urologist, Derbyshire Royal Infirmary.

  • C. A. L. GOULD BSc, MSc,

    1. Department of Urology, Derbyshire Royal Infirmary, Derby
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      C. A. L. Gould, BSc, MSc, Clinical Affairs Manager, Bard Ltd.

  • T. M. SUTTON PhD, CChem, FRSC

    1. Department of Urology, Derbyshire Royal Infirmary, Derby
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      T. M. Sutton, PhD, CChem, FRSC, Director of Clinical Affairs, Bard Ltd.


Department of Urology, Derbyshire Royal Infirmary, London Road, Derby DEI 2QY.

Abstract

Summary A group of 69 community patients undergoing long-term urethral catheterisation for urinary incontinence took part in this study; 33 patients with a mean age of 70.03 years (± 16.6) received the Dow Corning Silastic catheter (16 F 10-ml balloon) and 36 patients with a mean age of 75.61 years (± 12.6) received the Bard Biocath catheter (16 F 10-ml balloon). Over a 16-week period catheters were monitored every 2 weeks and changed as necessary. The Bard Biocath catheter remained in situ for an average of 89.61 days (± 35.31) and the Silastic catheter remained in situ for an average of 56.7 days (± 38.8); this difference was statistically significant.

Used catheters were analysed for encrustation using scanning electron microscopy (SEM). The average time in situ for non-encrusted Biocath catheters was 83.7 days and 25.28 days for non-encrusted Silastic catheters.

It was found that 70% of patients who received Biocath catheters preferred them to their previous catheters whereas only 30% of patients in the Silastic group preferred the trial catheter. The incidence of bypassing was 28% in the Biocath group and 52.8% in the Silastic group.

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