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

OBJECTIVE: To determine if the Bard Inlay Optima (BIO) with its anti-inflammatory pHreecoatTM stent coating had reduced SRS 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).

METHODS: A prospective, double-blinded, randomized controlled trial was performed on patients receiving unilateral retrograde DJ stents for urolithiasis or pelviureteric junction (PUJ) obstruction at three public Urology services. 140 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 post-operative opioid use.

RESULTS: No significant difference was found between the two stents in terms of index scores for all USSQ domains, early stent removal or post-operative 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 = 0.05). The CUS was also associated with higher rate of re-presentation to hospital at W1 (n=10, 16% vs n=1, 2%, p <0.001) and W3 (n=15, 25% vs n=3, 5%, p <0.001). This did not remain significant when adjusted to site of recruitment (W1 p = 0.27; W3 p = 0.22).

CONCLUSIONS: The BIO's anti-inflammatory pHreecoatTM stent coating did not translate to any significant difference in overall post-operative symptoms across urinary, pain, general and sexual health domains.