Date of ISAC Approval:
Stress urinary incontinence (SUI) is the involuntary leakage of urine on effort or exertion or on sneezing or coughing, the most common type of urinary incontinence reported by women. To date, little information about suicide in women diagnosed with SUI is available. Duloxetine has been approved for SUI. Because it is also an antidepressant, patients are warned about a potential risk for suicidality (suicidal thoughts or actions). The proposed study will look at differences in suicidality among stress incontinent women treated with duloxetine and another group of SUI women not receiving duloxetine. This information will help healthcare professionals, patients and regulatory agencies when looking at information from other data sources, e.g. suicidality cases voluntarily reported to regulatory authorities.
Stress urinary incontinence (SUI) is the involuntary leakage of urine on effort or exertion or on sneezing or coughing, the most common type of urinary incontinence reported by women. To date, no background suicidality rates specifically in stress incontinent women are available in the published literature. The proposed study is to evaluate the rates of suicidality for the SUI diagnosed women either treated with duloxetine or not receiving duloxetine. Rates of suicidality will also be estimated for SUI women and a comparable sample of women without urinary incontinence (UI) seen in the same general practitioner's offices. All analyses will be performed accounting for demographics and clustering by medical practice. Covariates of interest are known predictors of suicidality, such as a diagnosis of depression, past history of non-fatal suicide attempts, a diagnosis of other psychiatric conditions, history of psychiatric hospitalizations, use of antidepressants as documented in the available medical records (pertinent Read or OXMIS Medical Codes specified in the Appendix), and the presence of comorbid serious conditions, if warranted. The proposed study is a repeated analysis, and the previous protocol (# 10_185) was approved on 18th January 2011.
Health Outcomes to be Measured:
Suicide attempt Completed suicide Non-fatal suicide attempt Suicide ideation
Hu Li - Chief Investigator - Eli Lilly & Co - UK
Dustin Ruff - Researcher - Eli Lilly & Co Ltd - US Headquarters
Jonathan Swain - Researcher - Eli Lilly & Co Ltd - US Headquarters
Mark Bangs - Researcher - Eli Lilly & Co Ltd - US Headquarters