Ureteral Calculi, Ureterolithiasis
Conditions
Keywords
Ureterolithiasis, Alpha1-blocker, Lower ureteral stone
Brief summary
Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
Detailed description
Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs. Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.
Interventions
DRUGTamsulosin
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
DRUGPlacebo
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Sponsors
Ministry of Health, France
Yamanouchi
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult over 18 years * Emergency admission for a ureteral colic * Radio-opaque ureterolithiasis * Stone of 2 to 7 mm diameter * Informed written consent
Exclusion criteria
* Pregnancy or breast-feeding * Treatment with alpha or beta-blocker * Contraindication to tamsulosin (orthostatic hypertension, hepatic failure) * Complication needing surgery * Calculi spontaneous passage before randomization * Patient not available for a 6 week follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to stone elimination in days (censored criterion) | between day 1 and 42 |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first administration of corticoids or morphine in days | between day 1 and day 42 |
| Rate of adverse events | Within 42 days |
| Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) | between day 1 and 42 |
| Pain using Visual Analogue Scale | days 1, 2, 3 |
| Spontaneous stone elimination rate | days 1, 7, 14, 21, 28, 35, and 42 |
| Rate of need for corticoids or morphine | Within 42 days |
| Rate of need for surgery | Within 42 days |
| Time to surgery in days in patients with surgical elimination | between day 1 and day 42 |
| Rate of pain recurrences | within 42 days |
| Time to the first recurrence in days | between day 1 and day 42 |
| Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm) | days 1, 7, 14, 21, 28, 35, and 42 |
Countries
France
Outcome results
None listed