Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Peyronie’s disease - a non-interventional postauthorization safety study (201954)

Study type

• Study topic:
  Disease /health condition
• 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:
  Post-authorization safety study, Survey

Study drug and medical condition

• Name of medicine:
  XIAPEX
• Medical condition to be studied:
  Peyronie's disease

Population studied

• Short description of the study population:
  Physicians registering in the MAH’s Peyronie’s Trained Physicians database who have received Xiapex educational material for healthcare professionals for treatment of Peyronie’s disease. ; ; Upon registration in the Xiapex Peyronie’s Trained Physicians database the physician will consent to Sobi maintaining his/her information for the purpose of ensuring that only those physicians who are appropriately trained in the correct administration of the product and experienced in the diagnosis and treatment of male urological diseases can have access to Xiapex and for the purpose of assessing the effectiveness of the training programme. Physicians from Austria, Czech Republic, Denmark, Finland, Norway, Sweden, Spain and the United Kingdom registering in the Xiapex Peyronie’s Trained Physicians database will be asked to complete the survey. Distribution and return of surveys will be tracked.; Physicians that have not returned a completed form within 3 months following distribution will be asked to complete and return another survey for the purpose of soliciting information on nonresponding characteristics.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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.