Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: multicentre placebo controlled randomised trial of a calcium channel blocker(nifedipine) and an alpha blocker (tamsulosin).
Conditions
Interventions
Trade Name: Petyme MR
Product Name: Tamsulosin
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tamsulosin
CAS Number: 106133-20-4
Sponsors
University of Aberdeen
NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients presenting acutely with ureteric colic • Adults =18 to = 65 years of age • Presence of stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by IVU (intravenous urogram) with subsequent CTKUB confirmation within 12 hours • Stone within any segment of the ureter • Unilateral ureteric stone • Largest dimension of the stone =10 mm • Female subjects must be post menopausal (defined as 12 months with no menses without an alternative medical cause), permanently sterilised or willing to use two methods of contraception listed in the protocol prior to the start of dosing until at least 28 days after receiving the last dose of trial medication • Capable of giving written informed consent, which includes compliance with the requirements of the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Women who have a known or suspected pregnancy (confirmed by a pregnancy test) • Women who are breast-feeding • Asymptomatic incidentally found ureteric stone • Stone not confirmed by CTKUB • Stone with any one dimension >10 mm • Kidney stone without the presence of ureteric stone • Multiple (i.e. = 2) stones within ureter • Bilateral ureteric stones • Stone in a ureter draining a solitary kidney (either anatomically or functionally) • Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit) • Presence of urinary sepsis • Chronic kidney disease renal failure stage 4 or stage 5 (eGFR < 30ml/min) • Patients currently taking an a-blocker • Patients currently taking a calcium channel blocker • Patients currently taking PDE5 inhibitors • Contraindication or allergy to tamsulosin or nifedipine • Patients who are unable to understand or complete trial documentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the project is to determine the clinical effectiveness and cost-effectiveness of the use of an alpha blocker(tamsulosin) and a calcium channel blocker (nifedipine) in the management of symptomatic urinary stones. ; Secondary Objective: In the context of all patients receiving current standard care two pragmatic comparisons will be made evaluating medical expulsive therapies (MET) for facilitating ureteric stone passage: 1) MET (Alpha blocker [tamsulosin] or Calcium channel blocker [nifedipine]) versus placebo: and 2) Alpha blocker (tamsulosin) versus Calcium channel blocker (nifedipine). The hypotheses being tested are: 1) The use of MET will result in an absolute increase in the spontaneous stone passage rate of at least 25% compared with placebo and, 2) The use of an alpha blocker (tamsulosin) will result in an absolute increase of 10% in the spontaneous stone passage rate compared with a calcium channel blocker (nifedipine). ;Primary end point(s): Primary outcomes: 1) The primary outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage); 2) Incremental cost per quality adjusted life years (QALY) at 3 months. | — |
Countries
United Kingdom
Outcome results
None listed