A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Conditio
Phase 3
- Conditions
- Health Condition 1: null- Bladder dysfunction due to a problem with the nervous system leading to neurogenic detrusor overactivity.
- Registration Number
- CTRI/2013/10/004048
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
• Male or female subjects aged 6-17 years 11 months
• Subjects with stable neurological disease and neurogenic detrusor overactivity
• Evidence of a personally signed and dated informed consent document In addition, an assent from the subject will be obtained when appropriate, and when the potential subject is capable of providing assent.
Exclusion Criteria
• Concomitant medications which may increase the risk to subjects or confound study results
• Other medical conditions which may increase the risk to subjects or confound study results
• Contraindications to the use of fesoterodine or oxybutynin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum cystometric bladder capacityTimepoint: 12 weeks time frame
- Secondary Outcome Measures
Name Time Method Bladder compliance.Timepoint: 12 weeks time frame;Bladder volume at first Involuntary Detrusor Contractions (IDC).Timepoint: 12 weeks time frame;Detrusor pressure at maximum bladder capacity.Timepoint: 12 weeks time frame;Mean number of incontinence episodes/dayTimepoint: 12 weeks time frame;Mean number of micturitions and/or catheterizations/day.Timepoint: 12 weeks time frame;Mean urgency episodes/day if applicable.Timepoint: 12 weeks time frame;Mean volume voided per micturition or mean volume per catheterizationTimepoint: 12 weeks time frame;Presence of Involuntary Detrusor Contractions (IDC).Timepoint: 12 weeks time frame