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Sponsors and Collaborators: |
Rennes University Hospital Ministry of Health, France Yamanouchi |
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Information provided by: | Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT00151567 |
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.
Condition | Intervention | Phase |
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Ureterolithiasis Ureteral Calculi |
Drug: Tamsulosin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Interest of a Treatment With the alpha1-Blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones |
Enrollment: | 129 |
Study Start Date: | February 2002 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Tamsulosin
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Drug: Tamsulosin
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
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2: Placebo Comparator
Placebo
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Drug: Placebo
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service d'Urologie- Hôpital Pontchaillou | |
Rennes, France, 35033 | |
Service d'Urologie- Hôpital du Val de Grâce | |
Paris, France, 75005 | |
Service d'Urologie - Hôpital de La Milétrie | |
Poitiers, France, 86021 | |
Service d'Urologie - Hôpital Bretonneau | |
Tours, France, 37044 | |
Hôpital de Redon | |
Redon, France, 35600 | |
Service d'Urologie- Hôpital Robert Debré | |
Reims, France, 51092 |
Principal Investigator: | Francois Guillé, MD | Rennes University Hospital |
Study Chair: | Eric Bellissant, MD, PhD | Rennes University Hospital |
Responsible Party: | Rennes University Hospital ( Direction of Clinical Research ) |
Study ID Numbers: | AFSSAPS 010751, PHRC/00-01, CIC0203/004 |
Study First Received: | September 8, 2005 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00151567 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Ureterolithiasis Alpha1-blocker Lower ureteral stone |
Pathological Conditions, Anatomical Urinary Calculi Ureterolithiasis Urologic Diseases Urolithiasis |
Tamsulosin Ureteral Diseases Ureteral Calculi Calculi |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adrenergic Antagonists Adrenergic alpha-Antagonists Pharmacologic Actions |