Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Peyronie’s disease - a non-interventional post-authorization safety study (Sobi.Xiapex-PASS01)

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:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Physicians survey, Post-authorization safety study

Study drug and medical condition

• Medicinal product name:
  XIAPEX
• Medical condition to be studied:
  Peyronie's disease

Population studied

• Short description of the study population:
  Physicians from Austria, Czech Republic, Denmark, Finland, Norway, Sweden, Spain and the United Kingdom registering in the MAH’s Peyronie’s Trained Physicians database who have completed the Xiapex education material for usage of Xiapex in the treatment of Peyronie's Disease.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  The study objective is to evaluate the effectiveness of the Xiapex® educational material as an additional risk minimization measure for healthcare professionals in the treatment of Peyronie’s disease.
• Data analysis plan:
  Categorical data from the Implementation survey and the Follow-up survey will be summarized using frequency counts and percentages using the categories defined in the survey. Adverse events identified will be coded using MedDRA. Number of responders and non-responders will be summarized in total and by country, and also by specialty.