The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial

Abstract

The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.

Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial

“… 10 – 12 For example, 23% to 34% of OAB patients were completely continent 12 weeks after onabotulinumtoxinA 100 U treatment. 11 , 12 An extension study of 2 of the phase III trials found a median time to request retreatment of 7.6 months. 13 OnabotulinumtoxinA was generally well tolerated in these trials, with an increased risk versus placebo for urinary tract infection (UTI) and clean intermittent catheterization (CIC), required if predefined criteria were met for raised postvoid residual (PVR) urine volume.…”

Diagnosis and management of overactive bladder: A review

“…A post‐hoc analysis of a double‐blind, randomized study of patients treated with onabotulinumtoxinA, solifenacin, or placebo showed reductions in UI episodes/day in onabotulinumtoxinA‐treated patients (−3.19) were significantly greater than in solifenacin‐treated patients (−2.56; p = 0.022) 89 . Likewise, a meta‐analysis of 56 randomized controlled trials indicated patients who received onabotulinumtoxinA 100 U had greater reductions in UI, urgency, and micturition episodes versus anticholinergics and mirabegron 90 …”

“…A post-hoc analysis of a double-blind, randomized study of patients treated with onabotulinumtoxinA, solifenacin, or placebo showed reductions in UI episodes/day in onabotulinumtoxinA-treated patients (−3.19) were significantly greater than in solifenacintreated patients (−2.56; p = 0.022). 89 Likewise, a metaanalysis of 56 randomized controlled trials indicated patients who received onabotulinumtoxinA 100 U had greater reductions in UI, urgency, and micturition episodes versus anticholinergics and mirabegron. 90 Peripheral tibial nerve stimulation PTNS can be performed in an outpatient setting and involves the stimulation of the tibial nerve, a mix of L4-S3 fibers that modulate the micturition reflex, after percutaneous insertion of a needle above the medial malleolus.…”

Treatment patterns and costs among patients with OAB treated with combination oral therapy, sacral nerve stimulation, percutaneous tibial nerve stimulation, or onabotulinumtoxinA in the United States

“…Recently, the US Food and Drug Administration (FDA) approved the use of combination mirabegron/solifenacin for patients with OAB 14 based on the results of the Phase 3 SYNERGY I, SYNERGY II, and BESIDE studies 15‐17 . The treatment was incorporated in the AUA's 2019 guidelines for OAB (evidence Grade B) for use in subsequent lines of therapy after the failure of behavioural and oral monotherapies 1 .…”

“…13 Recently, the US Food and Drug Administration (FDA) approved the use of combination mirabegron/solifenacin for patients with OAB 14 based on the results of the Phase 3 SYNERGY I, SYNERGY II, and BESIDE studies. [15][16][17] The treatment was incorporated in the AUA's 2019 guidelines for OAB (evidence Grade B) for use in subsequent lines of therapy after the failure of behavioural and oral monotherapies. 1 The three clinical trials demonstrated that combination mirabegron/solifenacin therapy offered improved efficacy over either monotherapy or placebo across most outcomes considered, with a similar safety profile.…”