None listed
Conditions
Brief summary
Extracorporeal shockwave lithotripsy (SWL) is a non-invasive method of treating kidney and ureteric stones <2cm in size. SWL uses high frequency sound waves to break stones into small fragments, to allow it to pass through the urinary tract. Tamsulosin is a selective alpha-1-adrenoceptor antagonist that may lead to ureteral relaxation, reduce pain associated with stone passage and enhance the passage of stone fragments. It has been reportedly used for this purpose for more than a decade. A recent scientific study (meta-analysis by Chen and co-authors) combining the result of multiple randomised controlled trials looking at the effect of tamsulosin in assisting stone passage has been published in 2015. The study of 2093 patients found tamsulosin to be effective in improving the passage of stones and reducing the pain associated with stone passage following SWL. When looking only at the subgroup of 442 patients with stone size of 4-10mm, the study did not find tamsulosin to be useful in assisting stone passage. This is consistent with a recent study by Pickard in The Lancet journal, which found tamsulosin to be not useful in assisting stone passage or reducing pain in patients with stones in the ureter. In Australian practice, SWL are generally used for stones less than 1cm in size. Therefore, at the moment there are still conflicting data on the usefulness of tamsulosin in the cohort of stone patients we treat in Australia with SWL. We aim to answer this question in our randomised trial. The meta-analysis by Chen in 2015 also recommended further study looking into the ability of tamsulosin to reduce repeated SWL and the economic benefits of tamsulosin in this setting. Therefore, we also aim to answer the question of whether tamsulosin use after SWL leads to any economic benefit, which can come from the reduced cost of medical service delivery, and reduced economic burden on the society.
Interventions
Tamsulosin 0.4mg oral tablet daily for up to a maximum of 28 days commencing immediately following shockwave lithotripsy.
Instruction is given for patient to take the full 28 tablets. Compliance is monitored using a patient reported questionnaire to document the number of tablets actually taken.
There is no minimum treatment duration mandated.
Sponsors
Department of Urology, Case Hospital, Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) Patients presented for and completed shockwave lithotripsy treatment for renal or ureteric stones. 2) Patient must be eligible for fluoroscopic guided shockwave lithotripsy with no contraindications 3) Adults between 18 and 80 years of age (inclusive) 4) Presence of stone confirmed by computed tomography of the kidney, ureter and bladder 5) Capable of giving written informed consent, which includes compliance with the requirements of the trial
Exclusion criteria
1) Women who are breastfeeding 2) Patients currently taking an a-blocker 3) Patients currently taking PDE5 inhibitors 4) Contraindication or allergy to tamsulosin 5) Patient who are unable to understand or complete trial documentation
Outcome results
None listed