Evaluation of Tamsulosin in the Treatment of Ureteral Stones (TAMSULOSINE)

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Ureteral Calculi; Ureterolithiasis

Treatments: Drug: Tamsulosin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00151567

PHRC/00-01 (Other Identifier)

AFSSAPS 010751

CIC0203/004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Tamsulosin

Treatment:

Drug: Tamsulosin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo