Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial

Abstract

Background Double J (DJ) ureteral stents are commonly inserted after ureteroscopy (URS) procedures for stone treatment. However, stent-related symptoms are still a major issue. Objective To determine whether a commercially available pigtail suture stent (PSS) can reduce stent-related symptoms compared to a conventional DJ stent after uncomplicated URS. Design, setting, and participants We designed a randomized, single-blind, parallel-group trial from January to November 2020. The inclusion criteria were stone-free URS without intraprocedural complications. Patients with distal ureteral stones were excluded. Intervention Insertion of a PSS or DJ stent after URS. Outcome measurements and statistical analysis The primary endpoint was the Urinary Symptom Index score on the Ureteral Stent Symptoms Questionnaire (USSQ) 2 wk after URS. Secondary endpoints were USSQ domain scores and responses to individual USSQ questions at 2 d and 2 wk after surgery. Results and limitations A total of 78 patients were randomized and treated according to protocol. The Urinary Symptom Index score ( p = 0.004), overall Visual Analogue Scale (VAS) score ( p = 0.022), and the percentage of patients complaining of pain (63.9% vs 86.1%, p = 0.029) were significantly in favor of PSS at both 2 d and 2 wk after URS. At 2 d, the VAS score among patients with pain ( p = 0.025) and the General Health Index score ( p = 0.036) were significantly better in the PSS group. No severe complications occurred in either group. Study limitations are the exclusion of patients with distal ureteral stones and the limited sample size. Conclusions PSS significantly reduced stent-related symptoms after URS, in particular urinary symptoms and pain, compared to conventional DJ stents, and showed a good safety profile. Patient summary Stents are hollow tubes placed in the passage between the kidney and the bladder (ureter). The standard stent has two coiled ends (double J stent) to keep it in place in both the kidney and the bladder. We tested a commercial stent with two strings at the bladder end (pigtail suture stent) after procedures to remove stones from the upper urinary tract and found that it caused less stent-related symptoms compared to a double J stent. This trial is registered at Clinicaltrials.gov as NCT03344120.

Advances in ureteral stent technology

“…More recently, Bosio et al compared a commercially available PSS (JFil, Rocamed, Southborough, Massachusetts, USA) to a conventional double J ureteral stent (Vortek, Coloplast, Minneapolis, Minnesota, USA) removed at 2 weeks following ureteroscopy for treatment of nephrolithiasis [11 ▪ ]. Using the USSQ, urinary symptom index scores and pain scores were significantly lower for the PSS group [11 ▪ ]. In addition, there were no reports of stent failure with worsening hydronephrosis to suggest that the PSS was ineffective at relieving ureteral obstruction [11 ▪ ].…”

Silicone vs. Polyurethane Stent: The Final Countdown

“…Another recent RCT [ 28 ] suggests that using a “pigtail suture stent” (PSS) called the J-Fil (Rocamed, Monaco), with a fluted beak at the distal end attached to a suture rather than a “J” curve, of a conventional stent may reduce stent-associated symptoms.…”

10-Year Experience with Reinforced Ureteral Stents for Malignant Ureteral Obstruction

“…11,25,26 In recent studies including randomization and patient blinding, the results confirmed that suture stent like JFil ® significantly improved patient comfort. 27,28 About one third of the patients in our study were fitted with these innovative stents. The top priority for future stents suitable for malignant diseases should be to integrate the importance of stent stiffness and shape according to the data of our current knowledge.…”