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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Yamanouchi
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151567
First received: September 8, 2005
Last updated: December 3, 2012
Last verified: September 2008

September 8, 2005
December 3, 2012
February 2002
December 2006   (final data collection date for primary outcome measure)
Time to stone elimination in days (censored criterion) [ Time Frame: between day 1 and 42 ] [ Designated as safety issue: No ]
Time to stone elimination in days between day 1 and day 42 (censored criterion)
Complete list of historical versions of study NCT00151567 on ClinicalTrials.gov Archive Site
  • Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) [ Time Frame: between day 1 and 42 ] [ Designated as safety issue: No ]
  • Pain using Visual Analogue Scale [ Time Frame: days 1, 2, 3 ] [ Designated as safety issue: No ]
  • Spontaneous stone elimination rate [ Time Frame: days 1, 7, 14, 21, 28, 35, and 42 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Rate of need for surgery [ Time Frame: Within 42 days ] [ Designated as safety issue: No ]
  • Time to surgery in days in patients with surgical elimination [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
  • Rate of pain recurrences [ Time Frame: within 42 days ] [ Designated as safety issue: No ]
  • Time to the first recurrence in days [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
  • Rate of need for corticoids or morphine [ Time Frame: Within 42 days ] [ Designated as safety issue: No ]
  • Time to the first administration of corticoids or morphine in days [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: Within 42 days ] [ Designated as safety issue: Yes ]
  • - Time to stone elimination in days between day 1 and day 42 in patients with spontaneous elimination (quantitative criterion)
  • - Pain using Visual Analogue Scale
  • - Spontaneous stone elimination rate at days 1, 7, 14, 21, 28, 35, and 42
  • - Spontaneous stone elimination rate at days 1, 7, 14, 21, 28, 35, and 42 according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
  • - Rate of need for surgery
  • - Time to surgery in days between day 1 and day 42 in patients with surgical elimination
  • - Rate of pain recurrences
  • - Time to the first recurrence in days between day 1 and day 42
  • - Rate of need for corticoids or morphine
  • - Time to the first administration of corticoids or morphine in days between day 1 and day 42
  • - Rate of adverse events
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ureterolithiasis
  • Ureteral Calculi
  • 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)
  • Experimental: 1
    Tamsulosin
    Intervention: Drug: Tamsulosin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00151567
AFSSAPS 010751, PHRC/00-01, CIC0203/004
Yes
Direction of Clinical Research, Rennes University Hospital
Rennes University Hospital
  • Ministry of Health, France
  • Yamanouchi
Principal Investigator: Francois Guillé, MD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD Rennes University Hospital
Rennes University Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP