Clinical TrialID 5332

Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms

NCT01381120

Flank Pain|Urinary Bladder, Overactive

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Record Fields

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Clinical Trial Id
5332
Evidence Id
5332
Core Evidence Id
5332
Source Clinical Trial Id
5318
Herb2 Clinical Trial Id
HBCT005318
Nct Id
NCT01381120
Title
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
Status
Completed
Phase
Phase 4
Study Result
Yes
Study Condition
Flank Pain|Urinary Bladder, Overactive
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Intervention
DRUG: Solifenacin succinate treatment|DRUG: Oxycodone and acetaminophen combination treatment
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult, Older_Adult
Enrollment
84
Outcome Measure
Change in Post-ureteroscopy Stent-induced Pain, Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure., Baseline and 3 months.
Sponsor Collaborator
Barrie Urology Associates|Astellas Pharma Canada, Inc.
Funded By
OTHER
Location
Barrie Urology Associates - The Male/Female Health and Research Centre, Barrie, Ontario, L4M 7G1, Canada
Other Id
ARC-2010-03
Start Date
2010-10
Primary Completion Date
2012-06
Completion Date
2012-06
First Posted
2011-06-27
Results First Posted
2012-08-22
Last Update Posted
2012-08-30
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01381120
Title Cn
Title En
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
Bilingual Status
semi_complete