PURPOSE: To minimize stent-related symptoms, the proximal part of the Polaris™ stent is composed of a firm material and its distal part is composed of a soft material. The aim of this study was to compare stent-related symptoms of Polaris and Percuflex® stents and to assess the impacts of these stents on quality of life. PATIENTS AND METHODS: A total of 144 patients were randomized to a "test" group (Polaris; n=64) or a "conventional" group (Percuflex; n=80) at the time of ureteral stent insertion after ureteroscopic stone removal surgery. Stents were allocated using a randomization program. At 1 week postoperatively, patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire (USSQ), and patients were asked complete a 10 cm visual analogue scale (VAS). Mean scores for USSQ domains and mean VAS scores were compared. RESULTS:Mean patient age was 50.3 years, and the male-to-female ratio was 1:0.85. No significant intergroup differences were found in the domain scores of urinary symptoms (P=0.58), pain (P=0.87), general health (P=0.20), work (P=0.24), sexual activity (P=0.64), or additional problems (P=0.24). In addition, VAS scores were nonsignificantly different (P=0.11). Analysis of USSQ item scores, however, revealed the test group had better results for "presence of pain," "frequency of pain killer use," "difficulties with respect to hard physical activity," "fatigue," "frequency of rest," "stent-related impact on work," "antibiotics use" than the conventional group except for "outpatient department visits". CONCLUSION: Compared with the conventional Percuflex ureteral stent, the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms, pain, general health, sexual matters, or additional problems as determined by the USSQ or in VAS determined pain. Sub-analysis, however, showed that the Polaris has some advantages with respect to pain, physical activities, impact on work, and additional problems. Accordingly, the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent.
RCT Entities:
PURPOSE: To minimize stent-related symptoms, the proximal part of the Polaris™ stent is composed of a firm material and its distal part is composed of a soft material. The aim of this study was to compare stent-related symptoms of Polaris and Percuflex® stents and to assess the impacts of these stents on quality of life. PATIENTS AND METHODS: A total of 144 patients were randomized to a "test" group (Polaris; n=64) or a "conventional" group (Percuflex; n=80) at the time of ureteral stent insertion after ureteroscopic stone removal surgery. Stents were allocated using a randomization program. At 1 week postoperatively, patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire (USSQ), and patients were asked complete a 10 cm visual analogue scale (VAS). Mean scores for USSQ domains and mean VAS scores were compared. RESULTS: Mean patient age was 50.3 years, and the male-to-female ratio was 1:0.85. No significant intergroup differences were found in the domain scores of urinary symptoms (P=0.58), pain (P=0.87), general health (P=0.20), work (P=0.24), sexual activity (P=0.64), or additional problems (P=0.24). In addition, VAS scores were nonsignificantly different (P=0.11). Analysis of USSQ item scores, however, revealed the test group had better results for "presence of pain," "frequency of pain killer use," "difficulties with respect to hard physical activity," "fatigue," "frequency of rest," "stent-related impact on work," "antibiotics use" than the conventional group except for "outpatient department visits". CONCLUSION: Compared with the conventional Percuflex ureteral stent, the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms, pain, general health, sexual matters, or additional problems as determined by the USSQ or in VAS determined pain. Sub-analysis, however, showed that the Polaris has some advantages with respect to pain, physical activities, impact on work, and additional problems. Accordingly, the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent.
Authors: Charles D Scales; H Henry Lai; Alana C Desai; Jodi A Antonelli; Naim M Maalouf; Gregory E Tasian; Peter P Reese; Michele Curatolo; Kevin Weinfurt; Hussein R Al-Khalidi; Hunter Wessells; Ziya Kirkali; Jonathan D Harper Journal: J Endourol Date: 2020-11-16 Impact factor: 2.619