PURPOSE: We assessed the efficacy, safety and effects on quality of life of @entity9381 in @entity1 with neurogenic detrusor overactivity. MATERIALS AND METHODS: In this 52-week, international, multicenter, double-blind, randomized, placebo controlled trial 416 @entity1 with neurogenic detrusor overactivity and @entity322 (14 or more episodes per week) resulting from @entity15 (227) and @entity1566 (189) were treated with intradetrusor injections of @entity9381 (200 or 300 U) or placebo. The primary end point was the change from baseline in the mean number of @entity322 per week at week 6. Maximum cystometric capacity, maximum detrusor pressure during the first involuntary detrusor contraction and Incontinence Quality of Life total score were secondary end points. Adverse events were monitored. RESULTS: @entity9381 at a dose of 200 U in 135 @entity1 and 300 U in 132 decreased mean @entity322 at week 6 by 21 and 23 episodes per week, respectively, vs 9 episodes per week in 149 on placebo (each dose p<0.001). Also, maximum cystometric capacity, maximum detrusor pressure during the first involuntary detrusor contraction and Incontinence Quality of Life score were significantly improved over values in the placebo group (each dose p<0.001). Median time to @entity1 re-treatment request was greater for @entity9381 200 and 300 U than for placebo (256 and 254 days, respectively, vs 92). The most common adverse events were @entity293 and urinary retention. Of @entity1 who did not catheterize at baseline 10% on placebo, 35% on 200 U and 42% on 300 U initiated catheterization due to urinary retention. CONCLUSIONS: @entity9381 significantly improved neurogenic detrusor overactivity symptoms vs placebo. Clean intermittent catheterization initiation due to urinary retention appeared to increase in a dose dependent fashion. No clinically relevant benefit in efficacy or duration was identified for the 300 U dose over the 200 U dose.

Phase 3 efficacy and tolerability study of XXXX for @entity322 from neurogenic detrusor overactivity.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity322 :: ('MESH:D014549', 'Disease') :: ['urinary incontinence', 'urinary incontinence episodes'] @entity9381 :: ('MESH:C542870', 'Chemical') :: ['onabotulinumtoxinA', 'OnabotulinumtoxinA'] @entity1566 :: ('MESH:D013119', 'Disease') :: ['spinal cord injury'] @entity15 :: ('MESH:D009103', 'Disease') :: ['multiple sclerosis'] @entity293 :: ('MESH:D014552', 'Disease') :: ['urinary tract infection']
@entity9381 :: (MESH:C542870,Chemical) :: ['onabotulinumtoxinA']
