Urological and Genital Diseases: Acute renal colic Urological and Genital Diseases Acute renal colic
Conditions
Interventions
As of 28/03/2013 the trial status was changed to 'stopped' as the trial was closed in January 2011 due to recruitment issues.
Please note that, as of 11/04/2008, the anticipated start and end dates o
Sponsors
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: The total sample size required to produce statistically significant results is 206 patients (103 to receive placebo). All patients with renal colic with a visible calculus on X-ray which has been confirmed to be present within the ureter on intravenous urogram (IVU) will be asked to participate.
Exclusion criteria
Exclusion criteria: Patients will be excluded if pregnant, symptoms present for >14 days, evidence of infection or if they are already receiving treatment with tamsulosin or other calcium channel blocker.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures amended as of 11/04/2008: 1. Spontaneous stone passage within 6 weeks 2. Early intervention due to complications Primary outcome measures provided at time of registration: 1. The percentage of calculi passed spontaneously within 6 weeks 2. The mean time to spontaneous passage 3. The mean use of analgesia in the form of diclofenac (recommended first line analgesic) | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 11/04/2008: The following will be assessed at the end of the trial, i.e. time of stone passage or 6 weeks if stone not passed: 1. Percentage of calculi passed spontaneously within six weeks 2. Mean time to spontaneous passage 3. Mean use of analgesia in the form of diclofenac | — |
Countries
United Kingdom
Outcome results
None listed