Randomized Trial of Oxybutynin Extended Versus Immediate Release for Women Aged 65 and Older with Overactive Bladder: Lessons Learned from Conducting a Trial

Adverse events and treatment discontinuations of antimuscarinics for the treatment of overactive bladder in older adults: A systematic review and meta-analysis

“…Seventeen studies (7 RCTs, 3 sub-analyses of RCTs, and 7 pooled analyses of RCTs) made the inclusion criteria in which AEs were reported in the 65 or older population. Safety endpoints could not be extracted from one pooled analysis of RCTs (Griebling et al, 2009) as AEs were reported graphically; therefore, 16 studies were used in these analyses (Chapple et al, 2007a; Dubeau et al, 2014; DuBeau et al, 2012; Foote et al, 2005; Herschorn et al, 2011; Kraus et al, 2010b; Lackner et al, 2008; Malone-Lee et al, 2001; Minassian et al, 2007; Sand et al, 2011; Sand et al, 2004; Szonyi et al, 1995; Wagg et al, 2014; Wagg et al, 2013; Wagg et al, 2006; Zinner et al, 2002). …”

“…The 16 included studies included analyses on oxybutynin immediate-release (IR) (Herschorn et al, 2011; Minassian et al, 2007; Szonyi et al, 1995), oxybutynin extended-release (ER) (Lackner et al, 2008; Minassian et al, 2007; Sand et al, 2011; Sand et al, 2004), tolterodine IR (Malone-Lee et al, 2001; Sand et al, 2004), tolterodine ER (DuBeau et al, 2012; Wagg et al, 2014; Zinner et al, 2002), trospium ER (Sand et al, 2011), solifenacin (Herschorn et al, 2011; Wagg et al, 2006), darifenacin (Chapple et al, 2007a; Foote et al, 2005), fesoterodine (Dubeau et al, 2014; DuBeau et al, 2012; Kraus et al, 2010b; Wagg et al, 2013), and mirabegron (Wagg et al, 2014). Thirteen studies were placebo controlled.…”

“…Thirteen studies were placebo controlled. Two studies compared solifenacin and oxybutynin ER to oxybutynin IR (Herschorn et al, 2011; Minassian et al., 2007), one study compared oxybutynin ER to tolterodine IR (Sand et al, 2004), and one study compared fesoterodine to tolterodine ER (DuBeau et al, 2012). One study compared tolterodine ER, fesoterodine, mirabegron, and placebo (Wagg et al, 2014).…”

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

“…Following a review of the abstracts, 491 citations were rejected for not meeting study inclusion criteria (ie, wrong study type, not OAB; no elderly patients, not β‐3 adrenergic agonists or muscarinic antagonists), 381 were excluded following full‐text review, and 18 were excluded during the data extraction phase for not meeting study inclusion criteria—17 of these included elderly patients but were post‐hoc analyses of elderly sub‐groups; one paper reported the open‐label extension phase of a trial. A total of eight RCT papers met all the study inclusion criteria and were included in the review …”

“…Six of the eight RCTs were double‐blind and as such received “Strong” ratings for the “Blinding” criterion, while two were open‐label and thus received “Weak” ratings on the EPHPP tool . Likewise, when assessed by the AHRQ‐ER‐QA tool, six of the RCTs met the “Blinding” criterion, while two open‐label trials did not …”