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TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

ABSTRACT: Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention. The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden). The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option.The TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones. Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from randomisation.Determining whether ESWL is not inferior clinically and is cost-effective compared to ureteroscopic treatment as the initial management in adults with ureteric stones who are judged to require active treatment is relevant not only to patients and clinicians but also to healthcare providers, both in the UK and globally.ISRCTN registry, ISRCTN92289221 . Registered on 21 February 2013.

SUBMITTER: McClinton S

PROVIDER: S-EPMC5964896 | biostudies-other | 2018 May

REPOSITORIES: biostudies-other

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TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

McClinton Samuel S Cameron Sarah S Starr Kathryn K Thomas Ruth R MacLennan Graeme G McDonald Alison A Lam Thomas T N'Dow James J Kilonzo Mary M Pickard Robert R Anson Ken K Keeley Frank F Burgess Neil N Clark Charles Terry CT MacLennan Sara S Norrie John J

Trials 20180522 1

<h4>Background</h4>Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an interv ...[more]

PMID: 29788982

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Project description:ObjectiveTo 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 methodsIn 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.ResultsThe 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).ConclusionDouble 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.AbbreviationsKUB: plain abdominal radiograph of the kidneys, ureters and bladder; URSL: ureteroscopic lithotripsy; VAS: visual analogue scale.

Project description:Objective To investigate the efficacy and safety of alpha blockers in the treatment of patients with ureteric stones.Design Systematic review and meta-analysis.Data sources Cochrane Central Register of Controlled Trials, Web of Science, Embase, LILACS, and Medline databases and scientific meeting abstracts to July 2016.Review methods Randomized controlled trials of alpha blockers compared with placebo or control for treatment of ureteric stones were eligible. : Two team members independently extracted data from each included study. The primary outcome was the proportion of patients who passed their stone. Secondary outcomes were the time to passage; the number of pain episodes; and the proportions of patients who underwent surgery, required admission to hospital, and experienced an adverse event. Pooled risk ratios and 95% confidence intervals were calculated for the primary outcome with profile likelihood random effects models. Cochrane Collaboration's tool for assessing risk of bias and the GRADE approach were used to evaluate the quality of evidence and summarize conclusions.Results 55 randomized controlled trials were included. There was moderate quality evidence that alpha blockers facilitate passage of ureteric stones (risk ratio 1.49, 95% confidence interval 1.39 to 1.61). Based on a priori subgroup analysis, there seemed to be no benefit to treatment with alpha blocker among patients with smaller ureteric stones (1.19, 1.00 to 1.48). Patients with larger stones treated with an alpha blocker, however, had a 57% higher risk of stone passage compared with controls (1.57, 1.17 to 2.27). The effect of alpha blockers was independent of stone location (1.48 (1.05 to 2.10) for upper or middle stones; 1.49 (1.38 to 1.63) for lower stones). Compared with controls, patients who received alpha blockers had significantly shorter times to stone passage (mean difference -3.79 days, -4.45 to -3.14; moderate quality evidence), fewer episodes of pain (-0.74 episodes, -1.28 to -0.21; low quality evidence), lower risks of surgical intervention (risk ratio 0.44, 0.37 to 0.52; moderate quality evidence), and lower risks of admission to hospital (0.37, 0.22 to 0.64; moderate quality evidence). The risk of a serious adverse event was similar between treatment and control groups (1.49, 0.24 to 9.35; low quality evidence).Conclusions Alpha blockers seem efficacious in the treatment of patients with ureteric stones who are amenable to conservative management. The greatest benefit might be among those with larger stones. These results support current guideline recommendations advocating a role for alpha blockers in patients with ureteric stones.Systematic review registration PROSPERO registration No CRD42015024169.

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.

Dataset Information

TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

Publications

TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

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