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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00831701 |
Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.
The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.
Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.
Condition | Intervention |
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Ureteral Calculi |
Drug: Tamsulosin Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-Blind and Placebo-Controlled Study |
Enrollment: | 100 |
Study Start Date: | September 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Tamsulosin
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Drug: Tamsulosin
0.4 mg Tamsulosin once daily for 21 days
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2: Placebo Comparator
Placebo
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Drug: Placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Switzerland | |
Department of Urology, University Hospital Zürich, Switzerland | |
Zurich, Switzerland, 8091 |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
Responsible Party: | Department of Urology, University Hospital Zürich, switzerland ( Räto T. Strebel ) |
Study ID Numbers: | 1-Hermanns |
Study First Received: | November 19, 2008 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00831701 History of Changes |
Health Authority: | Switzerland: Ethikkommission |
Adrenergic alpha antagonists drug therapy tamsulosin ureter |
Pathological Conditions, Anatomical Urinary Calculi Neurotransmitter Agents Adrenergic Agents Urolithiasis Ureteral Calculi Ureteral Diseases |
Adrenergic alpha-Antagonists Calculi Ureterolithiasis Urologic Diseases Tamsulosin Adrenergic Antagonists |
Pathological Conditions, Anatomical Urinary Calculi Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Antineoplastic Agents Urolithiasis Physiological Effects of Drugs Ureteral Calculi |
Ureteral Diseases Adrenergic alpha-Antagonists Calculi Pharmacologic Actions Ureterolithiasis Urologic Diseases Therapeutic Uses Tamsulosin Adrenergic Antagonists |