New ureteral stent design does not improve patient quality of life: a randomized, controlled trial.

PURPOSE

Ureteral stents result in significant morbidity in many patients. Manufacturers have altered stent design and composition to minimize symptoms. The Polaris™ stent is made of a Percuflex® combination, providing a firm proximal aspect with a softer distal aspect to minimize symptoms. In this prospective, randomized study we compared symptoms and quality of life after stent insertion to determine whether this stent is better tolerated than the InLay® stent.

MATERIALS AND METHODS

Between September 2002 and September 2006 we randomized 159 patients requiring stent insertion for stone disease to receive the InLay or the Polaris ureteral stent. Patients were asked to complete the validated Ureteral Stent Symptom Questionnaire 2 weeks after stent insertion and 1 week after removal.

RESULTS

A total of 98 patients completed and returned each questionnaire, including 45 with the InLay and 53 with the Polaris. There were no significant differences between the groups on any health domain assessed. In the InLay and Polaris groups 91% and 94% of patients experienced pain with the stent in situ, which decreased to 40% and 43%, respectively, after stent removal. The urinary symptom score with the stent in situ was equal in the 2 groups (32, maximum 55). Of the InLay and Polaris groups 60% and 66% of patients, respectively, would be against receiving a further stent due to symptoms (p = 0.79).

CONCLUSIONS

The Polaris stent, designed with the specific aim of improving urinary symptoms and pain associated with ureteral stents, continues to have a significant detrimental effect on patient quality of life.