Study of Silodosin to Facilitate Passage of Urinary Stones

Study Overview
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Brief Summary
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The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Official Title
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A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage

Conditions
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Ureteral Calculi, Kidney Stones, Urolithiasis

Intervention / Treatment
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* Drug: silodosin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age or older Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter Exclusion Criteria: Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis History of previous ureteral surgery or ureteral stricture on affected side History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer Moderate to severe renal impairment or severe liver insufficiency History of significant postural hypotension Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study History of allergy to alpha-blockers or oxycodone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: silodsosin<br> | Drug: silodosin<br>* one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* one placebo capsule orally, once daily, with food for up to 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. | The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter. | 4 weeks | 
| Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. | The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Spontaneous Stone Passage (Distal Stones) | Time to stone passage for distally-located stones is assessed by entries in subject diaries. | 4 weeks | 
| Outpatient Narcotic Analgesic Use for Pain Relief | Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use. | 4 weeks | 
| Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones) | At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4. | 4 weeks | 
| Time to Spontaneous Stone Passage (All Stones) | Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral calculi, renal colic, ureteral stones, kidney stones, medical expulsive therapy