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

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

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Adult patients (≥ 18 years of age) with urinary incontinence due to neurogenic detrusor overactivity , eg, as a result of spinal cord injury or multiiple sclerosis, or due to overactive bladder 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)
• Estimated number of subjects:
  250

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 India.
• Outcomes:
  All AEs that occur during BOTOX administration and/or after BOTOX administration during the follow-up period will be collected regardless of causal relationship to BOTOX, The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) instrument will be used to evaluate effectiveness. The ICIQ-SF will be administered to patients before the injection of BOTOX and at the next office visit within 1 to 4 months after injection of BOTOX. The evaluation will be based on the change in the total score before and after administration of the BOTOX.
• 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. Categorical variables (eg, gender) will be summarized by the number and percentage (%) of patients in each category. 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 Continuous variables (eg, age) will be summarized using descriptive statistics (number of non-missing values, mean, standard deviation, median, minimum and maximum values).

Documents

Study results

191622-140 (NDO in India) Abstract