Official Title: “Interest of a Treatment With the alpha1-Blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2006

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.

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Tamsulosin
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Time to stone elimination in days (censored criterion)
  • Time Frame: between day 1 and 42
    Safety Issue?: No

Secondary Measures

• Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)
  • Time Frame: between day 1 and 42
    Safety Issue?: No
• Pain using Visual Analogue Scale
  • Time Frame: days 1, 2, 3
    Safety Issue?: No
• Spontaneous stone elimination rate
  • Time Frame: days 1, 7, 14, 21, 28, 35, and 42
    Safety Issue?: No
• Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
  • Time Frame: days 1, 7, 14, 21, 28, 35, and 42
    Safety Issue?: No
• Rate of need for surgery
  • Time Frame: Within 42 days
    Safety Issue?: No
• Time to surgery in days in patients with surgical elimination
  • Time Frame: between day 1 and day 42
    Safety Issue?: No
• Rate of pain recurrences
  • Time Frame: within 42 days
    Safety Issue?: No
• Time to the first recurrence in days
  • Time Frame: between day 1 and day 42
    Safety Issue?: No
• Rate of need for corticoids or morphine
  • Time Frame: Within 42 days
    Safety Issue?: No
• Time to the first administration of corticoids or morphine in days
  • Time Frame: between day 1 and day 42
    Safety Issue?: No
• Rate of adverse events
  • Time Frame: Within 42 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rennes University Hospital

Overall Clinical Trial Officials and Contacts

Francois Guillé, MD Principal Investigator Rennes University Hospital  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151567

Study ID Number: AFSSAPS 010751

ClinicalTrials.gov Identifier: NCT00151567

Health Authority: France: Afssaps - French Health Products Safety Agency