Archives of Urology Category: Clinical Type: Pilot Study
A Pilot Study Comparing Foley Catheter and CystoSure Catheter Balloon Volumes and Pullout Forces in Female Cadavers
- James A Greenberg1*, Traci E Ito2
- 1 Harvard Medical School, Brigham & Women’s Hospital, Boston, United States
- 2 Department Of Minimally Invasive Gynecology Surgery, University Of Louisville Hospital, Louisville, United States
*Corresponding Author:
James A GreenbergHarvard Medical School, Brigham & Women’s Hospital, Boston, United States
Tel:+1 617-983-7003,
Email:jagreenberg@bwh.harvard.edu
Received Date: Jan 16, 2018 Accepted Date: Feb 07, 2018 Published Date: Feb 20, 2018
Abstract
To compare CystoSure catheters with Foley catheters at differing fill volumes to determine the force needed to remove the inflated catheter balloons from female cadaver bladders with the goal of providing normative data for potential future research.
Methods and materials
Seven CystoSure catheters and seven Foley catheters were placed into the bladders of 14 randomly assigned fresh, unembalmed female cadavers. The catheters were randomly assigned to be filled with either 5 ml or 10 ml of water. The catheters were than forcibly removed and the maximum force was recorded using a force gauge.
Results
The mean force required to remove the CystoSure catheters with the balloon filled with 5 ml and 10 ml of water was 3.10 kg ± 0.8 and 5.57 kg ± 0.9 respectively. The mean force required to remove the Foley catheters with the balloon filled with 5 ml and 10 ml of water was 1.24 kg ± 0.2 and 3.82 kg ± 1.0 respectively. There was no statistically significant difference in the force needed to forcibly remove a CystoSure catheter filled with 5 ml as compared with a Foley catheter filled with 10 ml (p=0.39).
Conclusion
As compared with an ovoid Foley catheter balloon filled with 10 cc of sterile water, a CystoSure catheter with a low-profile, open-ended, “pancake-shaped” balloon filled with only 5 cc of sterile water demonstrates a similar pullout force needed to forcible remove the balloon from the bladder through the urethra of unembalmed female cadavers.
Keywords
INTRODUCTION
In the most commonly used adult versions of Foley catheters, the manufacturers typically recommend filling the balloons with 10 ml of sterile saline [4]. Yet, despite the ubiquity of Foley catheters and almost a century of use in healthcare, only one study by Wu et al., quantified the retention forces generated by a 10 ml balloon, and this study was performed exclusively in male cadavers [5]. Recently, Ito et al., studied balloon volumes and pullout forces in female catheters and demonstrated a similar mean force required to remove a catheter with the balloon filled with 10 ml as Wu et al., demonstrated in male cadavers (3.84 kg vs. 3.40 kg respectively) [6]. In this pilot study, we compare CystoSure catheters with Foley catheters (Figure 1) at differing fill volumes to determine the force needed to remove the inflated catheter balloons from female cadaver bladders with the goal of providing normative data for potential future research.

METHODS AND MATERIALS
RESULTS
CS 10ml |
Foley 10ml |
CS 5ml |
Foley 10ml |
CS 5ml |
Foley 5ml |
|
Mean force |
5.57 ± 0.9 |
3.82 ± 1.0 |
3.10 ± 0.8 |
3.82 ± 1.0 |
3.10 ± 0.8 |
1.24 ± 0.2 |
p value |
0.094 |
0.388 |
0.015* |
|||
Mean difference |
1.75 |
-0.71 |
1.87 |
|||
Range |
2.92 to 6.42 |
2.28 to 4.92 |
1.02 to 3.82 |
|||
C.I. |
-0.47 to 3.97 |
-2.76 to 1.34 |
0.59 to 3.15 |
|||
Mean height |
18.1 ± 1.3 |
24.4 ± 2.6 |
14.1 ± 1.2 |
24.4 ± 2.6 |
14.1 ± 1.2 |
20.3 ± 0.8 |
p value |
0.0003* |
0.0001* |
0.0001* |
|||
Mean difference |
-6.36 |
-10.35 |
-6.21 |
|||
Range |
17.5 to 26.2 |
12.0 to 26.2 |
12.0 to 15.5 |
|||
C.I. |
3.72 to 9.01 |
7.7 to 13.01 |
4.85 to 7.58 |
|||
Mean width |
29.3 ± 0.8 |
26.4 ± 0.9 |
23.5 ± 0.5 |
26.4 ± 0.9 |
23.5 ± 0.5 |
21.1 ± 0.3 |
p value |
0.0172* |
0.0094* |
0.0027* |
|||
Mean difference |
2.87 |
-2.93 |
2.37 |
|||
Range |
25.5 to 30.9 |
20.7 to 23.9 |
20.7 to 23.9 |
|||
C.I. |
-4.896 to -0.837 |
1.197 to 4.670 |
-3.359 to -1.374 |
|||
Mean W/Ht |
1.6 ± 0.01 |
1.0 ± 0.1 |
1.7 ± 0.2 |
1.0 ± 0.1 |
1.7 ± 0.2 |
1.0 ± 0.1 |
p value |
0.0004* |
0.005* |
0.0044* |
|||
Mean difference |
0.57 |
-0.67 |
0.67 |
|||
Range |
0.97 to 1.65 |
0.97 to 1.91 |
0.99 to 1.91 |
|||
C.I. |
-0.7147 to -0.4186 |
-0.9965 to -0.3369 |
-0.9906 to -0.3494 |
CONCLUSION
Study limitations include the small sample size and the use of cadavers rather than live subjects. It is possible that in living subjects with normally perfused tissues at normal body temperatures and natural lubricity, our data would be slightly different. However, we stand by the use of fresh, unembalmed cadavers as the closest applicable model for study. We did not design the present study for the male population because we felt Wu et al., [5] had already provided sufficient data in that regard.
SUMMARY
ACKNOWLEDGEMENT
REFERENCES
- AHRQ (2015) AHRQ patient safety toolkit helps hospitals reduce Catheter-Associated Urinary Tract Infections (CAUTI) AHRQ, Rockville, Maryland, USA.
- Kaplan JA, Carter JT (2018) Near-perfect compliance with SCIP Inf-9 had no effect on catheter utilization or urinary tract infections at an academic medical center. Am J Surg 215: 23-27.
- Greenberg JA, Grazul Bilska AT, Webb BT, Sun X, Vonnahme KA (2017) A preliminary evaluation of ovine bladder mucosal damage associated with 2 different indwelling urinary catheters. Urology 110: 248-252.
- Bard Medical (2010) Bard® Foley catheter inflation/deflation guidelines: Proper catheter inflation. Bard Medical, Covington, Georgia.
- Wu AK, Blaschko SD, Garcia M, McAninch JW, Aaronson DS (2012) Safer urethral catheters: How study of catheter balloon pressure and force can guide design. BJU Int 109: 1110-1114.
- Ito TE, Greenberg JA. A pilot study of Foley catheter balloon volumes and pullout forces in female cadaver. Publication pending.
Citation:Ito TE, Greenberg JA (2018) A Pilot Study Comparing Foley Catheter and CystoSure Catheter Balloon Volumes and Pullout Forces in Female Cadavers. Arch Urol 1: 001.
Copyright: © 2018 James A Greenberg, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
