Study of Silodosin to Facilitate Passage of Urinary Stones

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
silodsosin	silodosin	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	4 weeks	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.
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Outpatient Narcotic Analgesic Use for Pain Relief	4 weeks	Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
Time to Spontaneous Stone Passage (All Stones)	4 weeks	Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	4 weeks	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.
Time to Spontaneous Stone Passage (Distal Stones)	4 weeks	Time to stone passage for distally-located stones is assessed by entries in subject diaries.

Locations (2): Watson Investigational Site
🇺🇸
Virginia Beach, Virginia, United States
Watson Investigative Site
🇺🇸
North Kansas City, Missouri, United States