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

This study has been completed.
Study NCT00151567.   Last updated on September 29, 2008.   Information provided by Rennes University Hospital

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Descriptive Information Fields
Brief Title  Evaluation of Tamsulosin in the Treatment of Ureteral Stones
Official Title  Interest of a Treatment With the alpha1-Blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Time to stone elimination in days (censored criterion) [ Time Frame: between day 1 and 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Ureterolithiasis
Ureteral Calculi
Intervention  Drug: Tamsulosin
Drug: Placebo
MEDLINE PMIDs 16045553,   8957159
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  129
Start Date  February 2002
Completion Date December 2006
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  France
Administrative Information Fields
NCT ID  NCT00151567
Organization ID AFSSAPS 010751
Secondary IDs †† PHRC/00-01, CIC0203/004
Study Sponsor  Rennes University Hospital
Collaborators †† Ministry of Health, France
Yamanouchi
Investigators 
Principal Investigator:     Francois Guillé, MD     Rennes University Hospital    
Study Chair:     Eric Bellissant, MD, PhD     Rennes University Hospital    
Information Provided By Rennes University Hospital
Verification Date September 2008
First Received Date  September 8, 2005
Last Updated Date September 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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