N31.8
Conditions
Interventions
Group 1: intravesical oxybutynin hydrochloride solution (VESOXX®)
UPSIDE is a prospective, multicenter, non-interventional observational study to collect real world data from clinical and specialist treatment practice with VESOXX®.
The observation of the patients wi
Sponsors
Farco-Pharma GmbH
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pediatric (6 years and older) and adult male and female patients. The patient with multiple sclerosis (male or female) is at least 18 years old. 2. Patients suffering from neurogenic detrusor overactivity as a result of spinal cord injury, spina bifida (meningomyelocele) or multiple sclerosis. 3. Patients who have not been adequately treated with their previous therapy (oral anticholinergics/patches, intravesical oxybutynin on prescription, onabotulinumtoxin A, etc.) due to lack of efficacy and/or poor tolerability. 4. The decision to initiate treatment with/switch to VESOXX® in accordance with the current SmPC has been made independently of the study. 5. Patients who have consented in writing to retro- and prospective pseudonymized data collection.
Exclusion criteria
Exclusion criteria: 1. Patients enrolled in a clinical trial at the time of study initiation or during the study. 2. Patients who are already on VESOXX® or who are supposed to receive VESOXX® in the same dosage as an existing therapy with intravesical oxybutynin. 3. Patients with a contraindication as defined in the current SmPC for VESOXX®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study objective: To determine anamnestic and urodynamic predictors of therapeutically satisfactory dose titration during treatment initiation of or change to VESOXX®. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study objectives: - To assess user handling and application of the VESOXX® prefilled syringe and adapter. - To determine adherence and persistence of VESOXX® treatment and reasons for non-adherence/persistence, if any. - Characteristics of adherent/persistent patients - Surveying of the indication-specific quality of life of the patients over the observation period (SF Qualiveen®) - Description of type and sequence of pre- and concomitant therapies and correlation with various clinical/urodynamic parameters - Evaluation of the tolerability profile | — |
Countries
Germany
Contacts
Public ContactKathrin Kletschka
Real World Evidence Germany GmbH
Outcome results
None listed