Assessing the Impact of Ureteral Stent Design on Patient Comfort

Abstract

Purpose This study assessed near-term comfort of newly designed ureteral study stents or marketed control stents (Polaris™, Percuflex Plus®). Study stents substituted distal 6Fr pigtail ends with ≤3Fr loops. Reduced material in situ was hypothesized to enhance comfort. Utility of the patient self-administered Ureteric Stent Symptoms Questionnaire (USSQ) was assessed. Materials and Methods This 4-arm, multicenter study enrolled adults requiring retrograde unilateral ureteral stent placement for 4–28 days. USSQ administration occurred prior to placement (Baseline), at Day 4 post-placement, and Day 30 post-removal. 236 patients were randomized (1:1:1:1 ratio): Short Loop Tail (n=60), Long Loop Tail (n=59), Percuflex Plus (n=64); and Polaris (n=53). Results Overall, pain worsened from Baseline-Day 4 and improved from Day 4-Day 30. Mean pain medication usage peaked for all stents at Day 1 post-placement. Common device-related symptoms were mild or moderate in severity including flank pain (n=47 patients), hematuria (n=39), dysuria (n=34), frequent urination (n=30), and urinary urgency (n=27). Six patients experienced 9 device-related adverse events requiring hospitalization. All adverse events resolved, most within 3 days of in-patient treatment. Conclusions Although not statistically significant, patients stented with the Short Loop Tail had lower USSQ pain scores at Day 4 post-placement and lower pain medication usage at Day 1 post-placement, when pain peaked for all stent groups, suggesting that ureteral stent comfort, especially pain, may be improved with less material in situ. The USSQ may be better suited for longer-term comparisons among stented and non-stented patients rather than in this short term ureteral stent trial.

Prevention and treatment of symptoms associated with indwelling ureteral stents: A systematic review

“…However, there is conflicting data, too. Besides the trial by Lingeman et al 29 that could not even show significant advantages for markedly reduced intravesical stent material discussed above, our own study group recently could not find an influence of intravesical stent position on the associated morbidity as measured by USSQ total score and subscores. 40 Remarkably, this prospective assessment of 73 patients showed a high flexibility of the stent location during the indwelling time, bringing the approach to assess the intravesical stent position by X-ray into question.…”

“…This novel design was assessed in 2009 by Lingeman et al within a multicenter trial. 29 The authors randomized 236 patients in a 1:1:1:1 ratio to short loop tail stents, long loop tail stents, Percuflex Plus and Polaris stents. Although the study showed slight advantages of the short loop tail stent regarding the USSQ pain score, it was terminated early, as interim analysis showed no significant differences between the study arms.…”

α1-blockers for the reduction of ureteric stent-related symptoms: A systematic review and meta-analysis

“…Various ureteral stents and therapeutic agents have been investigated for their potential to reduce ureteric stent-related symptoms (USS), including ureteral stents composed of softer biomaterials, stents with various sizes and shapes, and drug eluting ureteral stents with various coatings (9)(10)(11). Furthermore, nonsteroidal anti-inflammatory drugs, calcium channel antagonists, α-adrenoceptor blockers and anticholinergics have been investigated in various clinical trials to alleviate USS in patients following ureteral stenting (9,12,13).…”

Effects of Terazosin and Tolterodine on Ureteral Stent Related Symptoms: A Double-Blind Placebo-Controlled Randomized Clinical Trial

“…Some etiologies have been hypothesized for their complications including mechanical irritation of the bladder trigone, urine renal reflux resulting obstruction, bacterial colonization, stent positioning as well as stent size and design (1,3,(6)(7)(8)(9)(10). Strategies for managing stent complications include accurate stent indications, stenting maneuvers, stent design and use of medications (1,3).…”