The following is a summary of “A Prospective, Randomized Controlled Multicenter Trial Comparing the Bard Inlay Optima and the Cook Universa Soft Stent,” published in the NOVEMBER 2023 issue of Urology by Ngoo, et al.
For a study, researchers sought to assess whether the Bard Inlay Optima, equipped with its anti-inflammatory pHreecoat stent coating, offered a reduction in stent-related symptoms during Week 1 (W1) and Week 3 (W3) post-insertion in comparison to the Cook Universa Soft (CUS), as evaluated by the validated Ureteral Stent Symptoms Questionnaire (USSQ).
A double-blinded, randomized controlled trial was undertaken on patients undergoing unilateral retrograde double-J stent placement due to urolithiasis or pelvic ureteric junction obstruction across three public Urology services. From the eligible pool, 140 patients were randomized equally (1:1 ratio) to each stent type. The primary endpoints comprised the mean USSQ index scores across the urinary, pain, general, and sexual health domains at W1 and W3 post-insertion. Secondary endpoints encompassed specific USSQ question responses, early stent extractions, and the subsequent use of opioids.
The study results did not reveal any significant disparity between the two stents concerning the index scores across all USSQ domains, early stent removal rates, or postoperative opioid consumption. Notably, at W1, the CUS recorded higher symptom scores linked to self-reported urinary tract infection symptoms (3.1 ± 1.3 vs. 2.6 ± 1.3, P = .05). Moreover, patients with CUS had a heightened representation rate to hospitals both at W1 (n = 10, 16% vs. n = 1, 2%, P < .001) and W3 (n = 15, 25% vs. n = 3, 5%, P < .001). However, these observed differences did not maintain significance upon adjusting for the recruitment site (W1 P = .27; W3 P = .22).
Despite the anti-inflammatory pHreecoat stent coating of the Bard Inlay Optima, no notable differences emerged in overall postoperative symptoms spanning the domains of urinary, pain, general, and sexual health when compared to the Cook Universa Soft.
Source: goldjournal.net/article/S0090-4295(23)00681-7/fulltext