Bladder wall thickness in XXXX with symptoms of @entity2182 and detrusor overactivity: Results from the randomised, placebo-controlled shrink study.

@entity1 @entity1494 @entity2133 @entity2180 @entity2182
AIMS: Measurement of @entity1494 ( @entity1494 ) by transvaginal ultrasound (TVUS) may be a less invasive method to diagnose @entity2182 ( @entity2182 ) or detrusor overactivity (DO) and monitor response to therapy. This study assessed whether treatment with @entity2180 affects @entity1494 . METHODS: This was a double-blind, randomised, placebo-controlled, phase 4 study. Adult @entity1 with @entity2182 symptoms received @entity2180 5 or 10   mg or placebo once daily for 12 weeks. The co-primary endpoints were change from baseline to Week 12 in TVUS-measured @entity1494 and urinary nerve growth factor. Only results for @entity1494 are presented here. RESULTS: Overall, 547 @entity1 were randomised, 501 @entity1 had a baseline @entity1494 measurement, and change from baseline could be calculated for 478 @entity1 . Mean @entity1494 at baseline was 5.08   mm (range 2.2-11.1, SD   =   1.14) and was normally distributed. A significant reduction in @entity1494 from baseline to 12 weeks versus placebo was observed with @entity2180 5   mg (-0.42 vs. -0.16   mm, P   =   0.03), but not with the 10   mg dose or with pooled @entity2180 , considered the primary comparison. Both @entity2180 doses were associated with improvements in efficacy and @entity1 satisfaction endpoints versus placebo. @entity2180 was well tolerated, with @entity2133 being the most common adverse event. CONCLUSIONS: There was no consistent effect of @entity2180 on @entity1494 in @entity1 with @entity2182 /DO, despite improvements in efficacy endpoints. This study suggests that routine clinical assessment of @entity1494 with TVUS for monitoring the effects of @entity2182 /DO treatment is not clinically useful. Neurourol. Urodynam. 9999:1-7, 2015.    2015 Wiley Periodicals, Inc.
