A Prospective, Randomized, Blinded Comparison of Top-Vented Catheter Valve vs. Non-vented Catheter Valve Suction Damage to the Bladder in a Convenience Sample of Women Undergoing Urethral Support Surgery

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Background: Hospital admissions from catheter-based infections are a substantial cost to insurers and society. Thus, it is paramount that these admissions, which are several thousand dollars each, be minimized. Minimizing catheter damage to the bladder mucosa and its defenses is a factor in reducing or eliminating some of these infections.
A prior pilot study has shown that a single, brief, Foley catheter drainage of the bladder can cause significant damage by suctioning the bladder mucosa into the catheter drainage holes when the bladder is fully emptied. A top-vent catheter suction-relief valve located on the drainage tubing can minimize this suction damage to the bladder.
Women undergoing urethral support surgery for stress urinary incontinence were utilized as subjects, as one may photograph, map, and rate damage to the bladder mucosa before and after a single drainage event that occurs during catheter placement for pubovaginal sling surgery.
Methods: 40 women undergoing Monarc sling surgery were studied and randomized to 2 groups - one with an active top-vent catheter tubing valve and the second with an internally inactivated valve.
6 mapping pictures of the posterior and lateral bladder wall were obtained before sling placement, and were matched to 6 pictures obtained after the bladder suction drainage event.
The surgeon was blinded to whether the vent was active or inactivated, and rated the pre and post drainage mucosa as 1=no lesion evident, 2=Minor mucosal and blood vessel changes, 3=Major blood vessel changes seen, and 4=Major mucosal and major blood vessel changes seen. Major blood vessel change was defined a rupture of blood vessels and major mucosal changes were defined as hemorrhage into the submucosal layer. The 2 groups were compared using a paired Mann-Whitney U-test.
Results: There was both a clinically and statistically significant difference between the activated and inactivated top-vent groups. The groups were rated as an increase of 0.33 categories versus 1.86 categories in the above rating system on average for each patient (p<0.0001), thus making a highly statistically and clinically relevant difference.
Conclusions: Top-vented catheter valve tubing will produce a clinically and statistically significant difference in suction lesions of the bladder versus traditional non-vented catheter drainage tubing. This will be an important factor to study for prevention catheter-based hospital admissions.

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