Evaluation of citrate-based nutraceutical combinations and their impact on chemolysis in the management of urinary diversion device: a randomised double-blind placebo-controlled study on improved quality of life and clinical outcomes.

Purpose: We aimed to evaluate in a double-blind randomized placebo-controlled trial (RCT) the effectiveness of two citrate-based products in preventing ureteral stent encrustation in patients with severe urinary system damage requiring long-term stent placement and frequent replacements to prevent complications.

Methods: Men and women aged 50-80, with severe urinary system damage were randomized to Product 1, Product 2 or Placebo. Efficacy points included encrustation prevention analyzed by mean normalized Kidney, Ureter and Bladder (KUB) score, ease of stent removal, and rate of emergency room (ER) visits.

Results: Of 142 patients randomized (Product 1, n = 37; Product 2, n = 62; Placebo, n = 43) 142 received treatment and 138 reached 9 months of follow-up. At 3 months Product 1 was associated with significant improvements vs. Product 2 by means of mean normalized KUB (mnKUB) score (W = - 5.75, p < 0.001). At 6 months both Product 1 and Product 2 were associated with significant improvements vs. Placebo (W = - 7.05, p < 0.001) and (W=-6.55, p < 0.001) respectively. Similar results were obtained at 9 months (Product 1 vs. Placebo, W = - 4.84, p = 0.002; Product 2 vs. Placebo, W = - 4.15, p = 0.009). These outputs agree with that obtained for ease of stent removal, while no differences were found where evaluating the rate of ER visits in the three groups.

Conclusion: This study emphasises the efficacy of a combination of potassium and magnesium citrates, Phillantus niruri, Ceterach officinarum and hyaluronic acid (Product 1) in managing long-term ureteral stent dependency, enhancing clinical outcomes and improving patient quality of life (QOL).