Limitations of anticholinergic cycling in patients with overactive bladder (OAB) with urinary incontinence (UI): results from the CONsequences of Treatment Refractory Overactive bLadder (CONTROL) study

Funding informationAstellas Pharma Europe B.V Aims: To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial. Methods: Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg, or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL), Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires. Results: Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus Alan Wein led the peer-review process as the Associate Editor responsible for the paper.394 |

Section: Introductionmentioning

confidence: 99%

Patient‐reported outcomes from SYNERGY, a randomized, double‐blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients

Robinson

Kelleher

Staskin

et al. 2017

“…After the failure of the lowest dose of an AC, Chapple et al 14 demonstrated the superiority of increasing the dose of fesoterodine up to 8 mg compared with 4 mg to achieve optimal symptom relief, although with an increased risk of adverse effects. The retrospective CONTROL trial suggests that in the real world, the incremental improvements in incontinence outcomes achieved with anticholinergic cycling may be minimal 15 . Therefore, as the Delphi panel recommends, if the maximum allowed dose of an AC proves to be ineffective, it is preferable to switch to a non‐AC therapy than try another AC 15 .…”

Section: Discussionmentioning

confidence: 99%

Development of a flowchart reflecting the current attitude and approach towards idiopathic overactive bladder treatment in Belgium: A Delphi study

Ghijselings

Hervé

Aa³

et al. 2020

Aims Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even existing guidelines contain inconsistencies. We aimed to develop a treatment algorithm for iOAB for use in daily clinical practice. Methods From October 2018 till November 2019, a Delphi study was conducted to obtain expert consensus on the management of iOAB. Members from the Belgian Working Group of Functional Urology were asked to rate online statements, based on gaps and variabilities between the American Urology Association (AUA), European Association of Urology (EAU) and International Consultation on Incontinence (ICI) guidelines on iOAB. The consensus was reached if ≥75% of the panel agreed on the level of appropriateness. Two Delphi rounds and an open discussion session were held. Results Twenty out of 49 members completed the first round and 18 completed the second round. The consensus was reached on 44/143 statements and 15/56 statements in the first and second round, respectively. The consensus was reached on criteria by which to phenotype OAB patients, the terminology relating to the first‐, second‐ and third‐line treatment, the duration of therapies, the chronological order, and the choice between therapies. No consensus was reached on the role of percutaneous tibial nerve stimulation (PTNS) in the treatment algorithm. Conclusions A flowchart reflecting the current attitude and approach of a Delphi expert panel towards the treatment of iOAB was developed. We propose its use in daily clinical practice to increase the standardization of OAB treatment.

“…However, AEs associated with antimuscarinics are recognized as a common cause of non‐adherence; dry mouth, the most prevalent AE, often leads to discontinuation of therapy . Further, incremental improvements in incontinence outcomes achieved by switching between antimuscarinics may be minimal . Selecting the drug that offers the best balance of efficacy and tolerability is an important step in the treatment of patients with OAB, and findings from this NMA suggest that solifenacin 5 mg/day may be the optimum treatment relative to other antimuscarinics for providing this balance.…”

Section: Discussionmentioning

confidence: 99%

Comparative efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents in overactive bladder: A systematic literature review and network meta‐analysis

Nazir

Kelleher

Aballéa

et al. 2017

Aims:To compare efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents for the treatment of overactive bladder (OAB).Methods: Literature searches of MEDLINE, Embase, and the Cochrane Library were undertaken to identify randomized controlled trials in OAB (2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015) for antimuscarinic agents. A network meta-analysis (NMA) was performed to estimate efficacy and tolerability outcomes for solifenacin 5 mg/day relative to other antimuscarinics. Results:The NMA included 53 eligible trials (published, n = 48; unpublished on search date, n = 5). Solifenacin 5 mg/day was significantly more effective than tolterodine 4 mg/ day for reducing incontinence and urgency urinary incontinence (UUI) episodes, but significantly less effective than solifenacin 10 mg/day for micturition; no other statistically significant differences were noted for efficacy. Solifenacin 5 mg/day had a statistically significant lower risk of dry mouth compared with darifenacin 15 mg/day, fesoterodine 8 mg/day, oxybutynin extended-release 10 mg/day, oxybutynin immediaterelease (IR) 9-15 mg/day, tolterodine IR 4 mg/day, propiverine 20 mg/day, and solifenacin 10 mg/day. There were no significant differences between solifenacin 5 mg/day and other antimuscarinics for risk of blurred vision, or for 11 of 17 active comparators for risk of constipation. Conclusions:This NMA suggests that the efficacy of solifenacin 5 mg/day is at least similar to other common antimuscarinics across the spectrum of OAB symptoms analyzed, and is more effective than tolterodine 4 mg/day in reducing incontinence and UUI episodes. Solifenacin 5 mg/day has a lower risk of dry mouth compared with several agents. K E Y W O R D Santimuscarinics, blurred vision, constipation, dry mouth, incontinence, micturition, solifenacinThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.