title: Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications.Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation.This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones.
  
  
  METHODS
  The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo.Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups.
  
  
  BACKGROUND
  ISRCTN69423238; EudraCT number: 2010-019469-26.
authors.affiliation: Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 2ZN, Scotland. smcclinton@nhs.net.
authors.forename: Sam
authors.initials: S
authors.lastname: McClinton
authors.forename: Kathryn
authors.initials: K
authors.lastname: Starr
authors.forename: Ruth
authors.initials: R
authors.lastname: Thomas
authors.forename: Graeme
authors.initials: G
authors.lastname: McLennan
authors.forename: Gladys
authors.initials: G
authors.lastname: McPherson
authors.forename: Alison
authors.initials: A
authors.lastname: McDonald
authors.forename: Thomas
authors.initials: T
authors.lastname: Lam
authors.forename: James
authors.initials: J
authors.lastname: N'Dow
authors.forename: Mary
authors.initials: M
authors.lastname: Kilonzo
authors.forename: Robert
authors.initials: R
authors.lastname: Pickard
authors.forename: Ken
authors.initials: K
authors.lastname: Anson
authors.forename: Jennifer
authors.initials: J
authors.lastname: Burr
mesh_terms: D000293:Adolescent; D058668:Adrenergic alpha-1 Receptor Antagonists / Q000191:economics / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000191:economics / Q000627:therapeutic use*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D016527:Drug Costs; D005260:Female; D006801:Humans; D007297:Inpatients; D008297:Male; D008875:Middle Aged; D009126:Muscle Relaxation / Q000187:drug effects; D009130:Muscle, Smooth / Q000187:drug effects / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000191:economics / Q000627:therapeutic use*; D009543:Nifedipine / Q000191:economics / Q000627:therapeutic use*; D012107:Research Design; D013449:Sulfonamides / Q000191:economics / Q000627:therapeutic use*; D000077409:Tamsulosin; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D006113:United Kingdom; D014513:Ureter / Q000000981:diagnostic imaging / Q000187:drug effects / Q000503:physiopathology; D014514:Ureteral Calculi / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D055815:Young Adult
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D002121:Calcium Channel Blockers; D009465:Neuromuscular Agents; D013449:Sulfonamides; D000077409:Tamsulosin; D009543:Nifedipine