Stress Urinary Incontinence and Suicidality Seen in the United Kingdom General Practice Research Database (F1J-MC-B056)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ARICLAIM

  CYMBALTA

  YENTREVE
• Medicinal product name, other:
  Xeristar
• Medical condition to be studied:
  Completed suicide

  Suicide attempt

  Suicidal ideation

Population studied

• Short description of the study population:
  Adult women who were registered in active medical practices with CPRD quality-verified records with a minimum follow up-time of 1 year.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  The primary objective of the study is to assess the association between suicide attempts (both non-fatal and completed) and receipt of duloxetine treatment in women with SUI compared to SUI women without duloxetine treatment, accounting for important demographic and medical history covariates.
• Outcomes:
  suicide attempts (both non-fatal and completed), suicidal ideation
• Data analysis plan:
  For the primary comparison of suicide attempt (non-fatal attempt & complete suicide) rates between SUI patients exposed vs SUI patients not exposed to duloxetine, a Cox proportional hazard model will be used to estimate adjust HR along with 95% CI. Sensitivity analysis 1)apply different grace periods other than 30 d & ITT analysis, 2)assess the impact of various definitions of suicidal outcomes. Post Hoc Analyses: this analysis will use propensity score stratification, as it maximizes the use of full sample size comparing to some other methods, ie propensity score matching. A pooled estimate of the variance of the estimated treatment effect can be obtained by pooling the variances of the stratum-specific treatment effects. PostHoc Analyses Using Additional Comparator Groups: like the main analysis, patients with baseline duloxetine exposure will be excluded, & patients with other antidepressants exposure at baseline & considered in the propensity score model.