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).