Evaluation of the Safety and Effectiveness of BOTOX® (Clostridium Botulinum Toxin Type A) in the Treatment of Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Post-marketing Surveillance Study inKorea

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes, Post-marketing surveillance

Study drug and medical condition

• Name of medicine, other:
  Botox
• Medical condition to be studied:
  Urinary incontinence

Population studied

• Short description of the study population:
  Adult patients (≥ 18 years of age) with urinary incontinence due to neurogenic detrusor overactivity (NDO), e.g., as a result of spinal cord injury (SCI) or multiple sclerosis (MS), or with symptoms of urge urinary incontinence, urgency, and frequency due to OAB who have an inadequate response to or are intolerant of an anticholinergic medication as evaluated and determined by treating physicians.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Urinary incontinence
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To evaluate the safety and effectiveness of BOTOX for the treatment of patients with urinary incontinence due to either NDO or OAB through active surveillance under routine clinical practice after the launch of BOTOX in Korea
• Outcomes:
  All AEs that occur during BOTOX administration and/or after BOTOX administration during the follow-up period, Response to the International Consultation on Incontinence questionnaire Short Form (ICIQ-SF) instrument
• Data analysis plan:
  Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. NDO and OAB patients will be analyzed together, as well as separately. For describing the incidence of adverse events, the frequency, cumulative incidence proportion, patient-year incidence rate, and 95% CI for the cumulative incidence measures will be displayed. Unless otherwise specified, the 95% CI of the proportions will be calculated using the exact method, and the 95% CI of the incidence rates will be constructed assuming the frequency of a particular event in a given period of time follows a Poisson distribution

Documents

Study results

BtxNDOOAB_Re-examination report_Eng_V1 0_clean_Final_20161202_Redacted