Randomized Controlled Trial to Evaluate the Efficacy and Safety of Silicone-Covered Metallic Mesh Stent Compared to Conventional Polymeric Stent in Malignant Ureteral Obstruction Patients.

PURPOSE: Clinical evidence directly comparing silicone-covered metallic ureteral stents with polymeric polyurethane Double-J stents for managing malignant ureteral obstruction remain limited. To evaluate the efficacy and safety of silicone-covered metallic stents compared with Double-J stents in patients with malignant ureteral obstruction.

METHODS

This prospective, randomized, open-label, single-center, single-surgeon trial (January 2020-November 2023) enrolled 65 patients (76 ureters) with malignant ureteral obstruction. Patients were randomized 1:1 to receive either a silicone-covered metallic stent (n = 38) or a Double-J stent (n = 38). Patency rates at 6 months post-procedure were assessed as the primary end point. The secondary endpoints included technical success, patency rate, adverse event rate, and patient discomfort, which was measured using the Ureteral Stent Symptom Questionnaire.

RESULTS

The patency survival rate was significantly higher in the silicone-covered stent group (p = 0.0024), with the control group exhibiting a 5.621 times higher risk of occlusion at 6 months (95% confidence interval 1.588-19.899, p = 0.0074). Both groups had comparable adverse events and discomfort rates, although the silicone-covered stent group reported a superior global quality of life (QoL) at 3 and 6 months.

CONCLUSIONS

In patients with malignant ureteral obstruction, silicone-covered metallic stents demonstrated superior patency maintenance and global QoL scores compared with Double-J stents, with no significant difference in safety or patient satisfaction. These findings suggest that silicone-covered stents may be a viable alternative for enhancing long-term ureteral patency and patient QoL.