A Prospective, Randomized Controlled Multicenter Trial Comparing the Bard Inlay Optima and the Cook Universa Soft Stent

Abstract

To determine if the Bard Inlay Optima with its anti-inflammatory pHreecoat stent coating had reduced stent-related symptoms at Week 1 (W1) and Week 3 (W3) post insertion compared to the Cook Universa Soft (CUS) using the validated Ureteral Stent Symptoms Questionnaire (USSQ). A prospective, double-blinded, randomized controlled trial was performed on patients receiving unilateral retrograde double-J stents for urolithiasis or pelviureteric junction obstruction at three public Urology services. One hundred forty patients that met inclusion criteria were randomized in a 1:1 ratio to each stent. Primary endpoints were the mean USSQ index scores for the urinary, pain, general, and sexual health domains at W1 and W3. Secondary endpoints were responses to individual USSQ questions, early stent removal, and postoperative opioid use. No significant difference was found between the two stents in terms of index scores for all USSQ domains, early stent removal or postoperative opioid use. The CUS had worse symptom scores at W1 relating to self-reported urinary tract infection symptoms (3.1±1.3 vs 2.6±1.3, P=.05). The CUS was also associated with higher rate of representation to hospital at W1 (n=10, 16% vs n=1, 2%, P<.001) and W3 (n=15, 25% vs n=3, 5%, P<.001). This did not remain significant when adjusted to site of recruitment (W1 P=.27; W3 P=.22). The Bard Inlay Optima's anti-inflammatory pHreecoat stent coating did not translate to any significant difference in overall postoperative symptoms across urinary, pain, general, and sexual health domains.