rodynamic and anamnestic profiles as a standardized instrument for treatment initiation and dose titration with VESOXX® - Real World study in patients with neurogenic detrusor overactivity

Recruiting

Conditions: N31.8
Other neuromuscular dysfunction of bladder

Registration Number: DRKS00028775

Lead Sponsor: Farco-Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 250

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

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®.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary study objective:<br><br>To determine anamnestic and urodynamic predictors of therapeutically satisfactory dose titration during treatment initiation of or change to VESOXX®.

Secondary Outcome Measures

Name	Time	Method
Secondary study objectives:<br><br>- To assess user handling and application of the VESOXX® prefilled syringe and adapter.<br><br>- To determine adherence and persistence of VESOXX® treatment and reasons for non-adherence/persistence, if any.<br><br>- Characteristics of adherent/persistent patients<br><br>- Surveying of the indication-specific quality of life of the patients over the observation period (SF Qualiveen®)<br><br>- Description of type and sequence of pre- and concomitant therapies and correlation with various clinical/urodynamic parameters<br><br>- Evaluation of the tolerability profile