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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. |
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| 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. |
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| 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 ] |
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| Condition † | Ureterolithiasis Ureteral Calculi |
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| Intervention † | Drug: Tamsulosin Drug: Placebo |
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| 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:
Exclusion Criteria:
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| 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 |
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| Investigators † |
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| Information Provided By | Rennes University Hospital | ||||||||
| Verification Date | September 2008 | ||||||||
| First Received Date † | September 8, 2005 | ||||||||
| Last Updated Date | September 29, 2008 | ||||||||
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