Laura Dhariwal1, Stephanie Chiu2, Charbel Salamon3. 1. Division of Urogynecology and Female Reconstructive Surgery, Atlantic Health System, Morristown, NJ, USA. laura.dhariwal@atlantichealth.org. 2. Atlantic Center for Research, Atlantic Health System, 435 South Street Suit 370, Morristown, NJ, 07960, USA. 3. Division of Urogynecology and Female Reconstructive Surgery, Atlantic Health System, Morristown, NJ, USA.
Abstract
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 withcontinuous 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.
RCT Entities:
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.