Trial | NCT00151567  Report issue

Title

Evaluation of Tamsulosin in the Treatment of Ureteral Stones
Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tamsulosin ...

  • Study Participants

    129
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.
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.
Study Started
Feb 28
2002
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Dec 04
2012
Estimate

Drug Tamsulosin

Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

Drug Placebo

Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

1 Experimental

Tamsulosin

2 Placebo Comparator

Placebo

Criteria 

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
No Results Posted