PURPOSE: We assessed the near term comfort of newly designed ureteral study stents or marketed control stents, including Polaris and Percuflex stents. Study stents had distal 6Fr pigtail ends with 3Fr or less loops. Decreased material in situ was hypothesized to enhance comfort. Usefulness of the patient self-administered Ureteral Stent Symptoms Questionnaire (Stone Management Unit, Southmead Hospital, United Kingdom) was assessed. MATERIALS AND METHODS: This 4-arm multicenter study enrolled adults requiring retrograde unilateral ureteral stent placement for 4 to 28 days. Ureteral Stent Symptoms Questionnaire administration was done before placement (baseline), on day 4 after placement and on day 30 after removal. A total of 236 patients were randomized in a 1:1:1:1 ratio to the short loop tail stent (60), the long loop tail stent (59), the Percuflex Plus stent (64) and the Polaris stent (53). RESULTS:Overall pain worsened from baseline to day 4 and improved from days 4 to 30. Mean pain medication use peaked for all stents on day 1 after placement. Common device related symptoms were mild or moderate in severity, including flank pain in 47 patients, hematuria in 39, dysuria in 34, frequent urination in 30 and urinary urgency in 27. Six patients experienced a total of 9 device related adverse events requiring hospitalization. All adverse events resolved, including most within 3 days of inpatient treatment. CONCLUSIONS: Although it was not statistically significant, patients stented with the short loop tail had lower questionnaire pain scores on day 4 after placement and lower pain medication use on day 1 after placement when pain peaked in all stent groups, suggesting that ureteral stent comfort, especially pain, may be improved by less material in situ. The Ureteral Stent Symptoms Questionnaire may be better suited for longer term comparisons in stented vs nonstented patients, rather than in this short-term ureteral stent trial.
RCT Entities:
PURPOSE: We assessed the near term comfort of newly designed ureteral study stents or marketed control stents, including Polaris and Percuflex stents. Study stents had distal 6Fr pigtail ends with 3Fr or less loops. Decreased material in situ was hypothesized to enhance comfort. Usefulness of the patient self-administered Ureteral Stent Symptoms Questionnaire (Stone Management Unit, Southmead Hospital, United Kingdom) was assessed. MATERIALS AND METHODS: This 4-arm multicenter study enrolled adults requiring retrograde unilateral ureteral stent placement for 4 to 28 days. Ureteral Stent Symptoms Questionnaire administration was done before placement (baseline), on day 4 after placement and on day 30 after removal. A total of 236 patients were randomized in a 1:1:1:1 ratio to the short loop tail stent (60), the long loop tail stent (59), the Percuflex Plus stent (64) and the Polaris stent (53). RESULTS: Overall pain worsened from baseline to day 4 and improved from days 4 to 30. Mean pain medication use peaked for all stents on day 1 after placement. Common device related symptoms were mild or moderate in severity, including flank pain in 47 patients, hematuria in 39, dysuria in 34, frequent urination in 30 and urinary urgency in 27. Six patients experienced a total of 9 device related adverse events requiring hospitalization. All adverse events resolved, including most within 3 days of inpatient treatment. CONCLUSIONS: Although it was not statistically significant, patients stented with the short loop tail had lower questionnaire pain scores on day 4 after placement and lower pain medication use on day 1 after placement when pain peaked in all stent groups, suggesting that ureteral stent comfort, especially pain, may be improved by less material in situ. The Ureteral Stent Symptoms Questionnaire may be better suited for longer term comparisons in stented vs nonstented patients, rather than in this short-term ureteral stent trial.
Authors: Ahmed R El-Nahas; Ahmed M El-Assmy; Ahmed M Shoma; Ibrahim Eraky; Mahmoud R El-Kenawy; Hamdy A El-Kappany Journal: J Endourol Date: 2006-01 Impact factor: 2.942
Authors: Ahmed R El-Nahas; Mohamed Tharwat; Mohamed Elsaadany; Ahmed Mosbah; Mohamed A Gaballah Journal: World J Urol Date: 2015-10-09 Impact factor: 4.226