ELMIRON: Observational Study for the Characterisation of Treatment Practice, Patients, and Symptom Load of Oral Pentosane Polysulfate Sodium for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine:
  ELMIRON
• Medical condition to be studied:
  Cystitis interstitial

  Off label use

Population studied

• Short description of the study population:
  Adult patients treated with elmiron® suffering from chronic interstitial cystitis
• 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:
  Chronic interstitial cystitis
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The objective of this study is to characterise the patients treated with elmiron® and how elmiron® is used (e.g. age, diagnostic criteria for prescription, dosage, duration of treatment, reasons for stopping treatment, and co-treatment). Primary objective = Characterisation of elmiron® treatment practice for the treatment of IC/BPS
• Data analysis plan:
  ELMIRON is a non-comparative, exploratory study not involving the formal testing of any preformulated hypotheses. Parameters are summarised by appr. key figures (number, percentage for categorical data, arithmetic mean, standard deviation, minimum, median, maximum, sample size for metric data). The Kaplan-Meier-Estimator used to model drug survival. Descriptive statistics are performed for all subjects and defined subgroups. The creation of additional subgroups is permissible. Differences between the groups are tested by the non-parametric Mann-Whitney Test and the χ² Test for significance in a purely exploratory fashion. The statistical analysis software Stata® is used for all statistical analyses.