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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 alpha-blocker (tamsulosin): study protocol for a randomized controlled trial

Lookup NU author(s): Rob Pickard

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


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 a-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/design: 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 (Continued on next page)


Publication metadata

Author(s): McClinton S, Starr K, Thomas R, McLennan G, McPherson G, McDonald A, Lam T, N'Dow J, Kilonzo M, Pickard R, Anson K, Burr J, SUSPEND Study Grp

Publication type: Article

Publication status: Published

Journal: Trials

Year: 2014

Volume: 15

Pages: 1-12

Online publication date: 20/06/2014

Acceptance date: 22/05/2014

Date deposited: 15/08/2014

ISSN (electronic): 1745-6215

Publisher: BioMed Central Ltd.

URL: http://dx.doi.org/10.1186/1745-6215-15-238

DOI: 10.1186/1745-6215-15-238


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Funding

Funder referenceFunder name
Chief Scientist Office of the Scottish Government Health and Social Care Directorates
80/71/01National Institute for Health Research Health Technology Assessment Programme

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