Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE) (URGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01786967|
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urge Urinary Incontinence||Drug: Fesoterodine Fumarate||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Experimental: Fesoterodine Fumarate
Participants will receive 4 mg of study drug for first 2 weeks, and then 8 mg of study drugs for 2 weeks.
Drug: Fesoterodine Fumarate
FDA approved anticholinergic medication used for treatment of urge urinary incontinence
Other Name: Toviaz
- Percentage With Treatment Success [ Time Frame: 4 weeks ]Treatment Success (Yes/No) was defined by the Treatment Benefit Scale (TBS). TBS is a 4-point scale which was dichotomized into Yes/No for the Treatment Success outcome. The scale asks participants to rate "My condition has been improved: 1= greatly improved, 2=improved, 3=not changed, 4= worsened." If a participant responded 1 (greatly improved) or 2 (improved), they were considered as a "Yes" for Treatment Success. If a participant responded 3 (not changed) or 4 (worsened), then they were considered as a "No" for Treatment Success.
- Percentage With Moderate to Severe Anticipated Drug Associated Adverse Events [ Time Frame: 4 weeks ]Outcome was defined as moderate to severe anticipated adverse events (AE) based on the NCI Common Terminology Criteria for Adverse Events (CTCAE). Each AE is graded 1-5 with Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, grade 5=Death-related to AE. Any side effect grade >= 2 considered a moderate to severe AE. Anticipated AEs included dizziness, somnolence, insomnia, confusion, cognitive impairment, dry eyes, blurry vision, dry mouth, constipation, nausea, dyspepsia and urinary retention. Example: dry mouth grades per CTCAE: Grade 1=symptomatic without significant dietary alteration; unstimulated saliva flow > 0.2 mL/min; Grade 2=symptomatic and significant oral intake alteration; unstimulated saliva flow 0.1 to 0.2 mL/min; Grade 3=symptoms leading to inability to adequately aliment orally; IV fluids, tube feedings or total parenteral nutrition indicated; unstimulated saliva < 0.1 mL/min.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786967
|United States, North Carolina|
|UNC-Chapel Hill, Dept of Ob/Gyn|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Jennifer M Wu, MD||UNC-CH|