Clinical effectiveness of new stent design: Randomized single-blind comparison of tail and double-pigtail stents

Background and Purpose: Stent morbidity appears to be secondary to lower ur inary tract irritation. In an effort to decrease stent morbidity, a "one si ze fits all" Tail stent (Microvasive [Boston Scientific] Natick, MA) was de veloped with a 7F proximal pigtail and 7F shaft which tapers to a lumenless straight 3F tail, Patients and Methods: We randomized 60 patients in a single-blind fashion t o a 7F tail stent or 7F double-pigtail Percuflex stent, Patients were evalu ated at the time of stent removal and 2 weeks later with a standardized que stionnaire assessing: irritative lower tract symptoms individually and on a total scale of 0 (no symptoms) to 30 (worst symptoms), obstructive lower t ract symptoms (on a total scale of 0-20), and upper tract irritative sympto ms (on a total scale of 0-10), Results: Patient age, weight, and height were similar in the two groups, Co mplications, including fever, urinary tract infections, emergency room visi ts, and the need for antispasmodics and pain medication, also demonstrated no significant difference, At the time of stent removal, patients who recei ved a tail stent had significantly less urinary frequency and a statistical ly significant (21%) decrease in overall irritative voiding symptoms (12.2 v 15.4; p = 0.048), Two weeks after stent removal, the total irritative voi ding symptoms was markedly decreased in both groups (7.1 in the Tail v 5.3 in the double-pigtail group; p = 0.15), Obstructive bladder and flank sympt oms were not significantly different in the two stent groups, either at the time of stent removal or at 2 weeks after removal, Conclusion: In this randomized, single-blind study, the 7F Tail stent produ ced significantly less irritative symptoms than did the standard 7F double- pigtail stent, Obstructive symptoms tended to be less with the new stent, w hile flank symptoms were similar.