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Ureteric stenting vs not stenting following uncomplicated ureteroscopic lithotripsy: A prospective randomised trial.

ABSTRACT:

Objective

To compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) and to evaluate whether stenting could be eliminated after the procedure, as there is no consensus about whether a ureteric stent should be placed after uncomplicated ureteroscopy for stone retrieval.

Patients and methods

In this randomised clinical trial (NCT04145063) 105 patients underwent uncomplicated URSL for ureteric stones. They were prospectively randomised into three groups: Group 1 (34 patients) with a double pigtail ureteric stent, Group 2 (35 patients) with a double pigtail ureteric stent with extraction string, and Group 3 (36 patients) with no ureteric stent placed after the procedure. The outcomes measured were: postoperative visual analogue scale (VAS) score for flank pain and dysuria score, urgency, frequency, suprapubic pain, haematuria, analgesia requirement, operative time, re-hospitalisation, and return to normal physical activity.

Results

The mean (SD) operative time was significantly longer in groups 1 and 2 compared to Group 3, at 22.2 (9.1), 20.2 (6) and 15.1 (7.1) min, respectively (P < 0.001). The results of the VAS for flank pain and dysuria scores, urgency, frequency, haematuria, and suprapubic pain showed a significant difference at all time-points of follow-up, being significantly higher in groups 1 and 2 compared to Group 3 (all P < 0.001). Further analysis showed that measured outcomes, and analgesia need for groups 1 and 2 were similar, at all time-points except at week 1 and 1 month where Group 2 patients' had less symptoms (P < 0.001).

Conclusion

Double pigtail ureteric stent placement appears to be unnecessary in procedures considered 'uncomplicated' by operating urologists during surgery. The advantages of the double pigtail ureteric stent with extraction string over the double pigtail ureteric stent only include earlier and easier removal with earlier relief of symptoms, and less analgesia requirements.

Abbreviations

KUB: plain abdominal radiograph of the kidneys, ureters and bladder; URSL: ureteroscopic lithotripsy; VAS: visual analogue scale.

SUBMITTER: Al Demour S

PROVIDER: S-EPMC7473245 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRenal stone disease is common and can cause emergency presentation with acute pain due to ureteric colic. International guidelines have stated the need for a multicentre randomised controlled trial (RCT) to determine whether a non-invasive outpatient (shockwave lithotripsy [SWL]) or surgical (ureteroscopy [URS]) intervention should be the first-line treatment for those needing active intervention. This has implications for shaping clinical pathways.ObjectiveTo report a pragmatic multicentre non-inferiority RCT comparing SWL with URS.Design, setting, and participantsThis trial tested for non-inferiority of up to two sessions of SWL compared with URS as initial treatment for ureteric stones requiring intervention.Outcome measurements and statistical analysisThe primary outcome was whether further intervention was required to clear the stone, and secondary outcomes included quality of life assessment, severity of pain, and serious complications; these were based on questionnaires at baseline, 8 wk, and 6 mo. We included patients over 16 yr with a single ureteric stone clinically deemed to require intervention. Intention-to-treat and per-protocol analyses were planned.Results and limitationsThe study recruited between July 1, 2013 and June 30, 2017. We recruited 613 participants from a total of 1291 eligible patients, randomising 306 to SWL and 307 to URS. Sixty-seven patients (22.1%) in the SWL arm needed further treatment compared with 31 patients (10.3%) in the URS arm. The absolute risk difference was 11.7% (95% confidence interval 5.6%, 17.8%) in favour of URS, which was inside the 20% threshold we set for demonstrating noninferiority of SWL.ConclusionsThis RCT was designed to test whether SWL is non-inferior to URS and confirmed this; although SWL is an outpatient noninvasive treatment with potential advantages both for patients and for reducing the use of inpatient health care resources, the trial showed a benefit in overall clinical outcomes with URS compared with SWL, reflecting contemporary practice. The Therapeutic Interventions for Stones of the Ureter (TISU) study provides new evidence to help guide the choice of modality for this common health condition.Patient summaryWe present the largest trial comparing ureteroscopy versus extracorporeal shockwave lithotripsy for ureteric stones. While ureteroscopy had marginally improved outcome in terms of stone clearance, as expected, shockwave lithotripsy had better results in terms of health care costs. These results should enable patients and health care providers to optimise treatment pathways for this common urological condition.

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