A urinary catheter valve is non-inferior to continuous bladder drainage with respect to post-operative UTIs: a randomized controlled trial.

Introduction And Hypothesis: Urinary tract infections (UTIs) are common with indwelling catheter use. Our primary aim was to compare UTI rates in women sent home after surgery with continuous bladder drainage versus a urinary catheter valve.

Methods: This was a non-inferiority prospective randomized controlled study between June 2016 to June 2019. Women who were being discharged home with a Foley catheter following urogynecologic surgery due to urinary retention were randomized to a continuous urinary drainage bag or a urinary catheter valve. The primary outcome of this study was post-operative UTI rates within 30 days of surgery. The secondary outcome was patient satisfaction, as determined by a Foley satisfaction questionnaire.

Results: Out of 97 women, 51 were randomized to continuous drainage and 46 to the urinary catheter valve. Comparing UTI rates, the urinary catheter valve (32.6%) was non-inferior to the continuous urinary drainage bag (33.3%). The upper bound of the 95% CI was less than the predetermined non-inferiority margin (difference 0.7%, 95% CI: -0.195, 0.180), and therefore non-inferiority criteria were met. Patients were more satisfied with the urinary catheter valve than with the continuous drainage bag (p ≤ 0.001).

Conclusions: Use of this urinary catheter valve increased patient satisfaction without affecting the post-operative UTI rate. This easy and inexpensive device could help patients have a better catheter experience and should be considered in women being discharged home with a urinary catheter.