Study of Silodosin to Facilitate Passage of Urinary Stones

• silodosin (Drug): one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
• placebo (Drug): one placebo capsule orally, once daily, with food for up to 4 weeks

Primary outcomes

• 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.
• 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.

Secondary outcomes

• Time to Spontaneous Stone Passage (Distal Stones) [4 weeks]: Time to stone passage for distally-located stones is assessed by entries in subject diaries.
• 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.
• 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 (All Stones) [4 weeks]: Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. (Primary), Number, participants: Silodsosin 36; Placebo 27
• Time to Spontaneous Stone Passage (Distal Stones) (Secondary), Mean, days: Silodsosin 19.6 (12 to 29); Placebo 22.0 (26 to )
• Outpatient Narcotic Analgesic Use for Pain Relief (Secondary), Mean, Days: Silodsosin 5.8 +/- 8.0; Placebo 5.5 +/- 6.8
• Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones) (Secondary), Mean, units on a scale: Silodsosin -2.6 +/- 2.5; Placebo -1.9 +/- 3.1
• Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. (Primary), Number, participants: Silodsosin 60; Placebo 52
• Time to Spontaneous Stone Passage (All Stones) (Secondary), Mean, days: Silodsosin 22.3 (26 to 31); Placebo 22.9 (26 to )

Adverse events

Serious adverse events by term

Other adverse events by term

• Scott Olsen, MPH, Study director, Watson Pharmaceuticals, Inc.