Overactive bladder anticholinergics and risk of incident dementia: a cohort study design using a triangulation approach

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G04BD) Drugs for urinary frequency and incontinence

  Drugs for urinary frequency and incontinence
• Medical condition to be studied:
  Hypertonic bladder

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1300000

Study design details

• Main study objective:
  To examine whether recurrent overactive bladder anticholinergic prescriptions are associated with increased dementia incidence versus receiving one prescription (separately in men and women).
• Outcomes:
  Time to dementia diagnosis, delirium, fracture, stroke, motor vehicle accident
• Data analysis plan:
  New user design cohort studies of patients in England prescribed OAB medications since 1998. Dementia incidence (using Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics mortality data) will be compared after applying a 3-year lag period between patients receiving a second OAB prescription to those only receiving one prescription using Cox regression with age as the time-scale. We are using a triangulation approach, hence performing various analyses to see if the findings are consistent with causality and examine confounding and selection biases. This includes additionally examining the outcomes of delirium, fractures and stroke (primarily with exposure as time-varying and no lag period).