None listed
Conditions
Brief summary
Ureteric colic (or Kidney stones) is a significant public health concern within Australia, affecting as many as 5-15% of adults. As a result, a significant number of Australians experience significant pain, hospital and outpatient visits, and the potential for more significant complications such as infection, kidney damage and the need for surgical treatments. Although several methods of medical treatments to improve care of such patients have been studied overseas, some of which appear promising, the practice of “medical expulsive therapy” for ureteric colic is not widely practiced in Australia. One such medication is Tamsulosin, which seems to have an effect on the ureter (tube from kidney to bladder) and helps stones pass. It is already in use for other urological conditions already in Australia, and studies overseas seem to show benefit for patients with Ureteric colic. Within Queensland Health there is substantial variation with regard to access to specialist urologist services. Benefits of medical therapies for ureteric colic may be even greater in geographically isolated areas without full time urology services. This study aims to determine if the addition of the drug Tamsulosin 0.4mg daily, in addition to usual standard care, will improve the rates of spontaneously passing stones less than 10mm in diameter, whether the drug has any effect on pain experienced by the patients, their need for surgery and complications. Patients who present to the participating emergency departments with Ureteric calculi, that fit the inclusion criteria will be randomly allocated to either the study medication (Tamsulosin 0.4mg daily) or placebo. The patients will then be closely monitored for four weeks, to determine if the stones pass spontaneously, or if any complications occur. At four weeks the study will be complete, patients who are yet to have passed the stone, would be referred to Urology for consideration of a procedure.
Interventions
The intervention group will recieve Tamsulosin 0.4mg orally, daily for 28 days (Standard care will include analgesia with Indomethicin 25-50mg orally three times a day or 100mg suppository twice a day AND Oxycodone 5-10mg orally three times a day as needed)
Sponsors
The Townsville Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Radiologically documented calculus in the distal ureter, less than or equal to 10mm diameter and no exclusion criteria.
Exclusion criteria
Paediatric Patients <18 years, Infection (fever > 38 degrees), Glomerular Filtration Rate < 60 ml/min/1.73m2, Calculus >1cm diameter, Solitary kidney, Transplanted kidney, History of ureteral stricture, Pregnancy or planning pregnancy, Allergic reaction to the study medication, Current calcium channel blocker or a1-blocker use, Hypotension (Systolic Blood Pressure < 100 mmHg)
Outcome results
None listed