A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and urinary Nerve Growth Factor in Female Subjects with Overactive Bladder and a Diagnosis of Detrusor Over...

Update Il y a 4 ans
Reference: EUCTR2008-005215-17

A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and urinary Nerve Growth Factor in Female Subjects with Overactive Bladder and a Diagnosis of Detrusor Overactivity – A double-blind, randomized, placebo-controlled, parallel group, multicentre study

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Extract

1. To evaluate the effect of solifenacin versus placebo on bladder wall thickness (BWT) after 12 weeks of treatment. 2. To evaluate the effect of solifenacin versus placebo on urinary Nerve Growth Factor (uNGF) normalized by urine creatinine level (uNGF/Cr) after 12 weeks of treatment in subjects with uNGF above laboratory quantification limit at baseline.


Inclusion criteria

  • Overactive Bladder