Trial reportWorld journal of urology2017
Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY).
Trial report in World journal of urology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01340027 (A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- Guideline for Medication Management of Distressing Symptoms in Older Patients Receiving End-of-Life Palliative Care.Journal of evidence-based medicine · 2026Guideline
- Pooled it
- Characterizing the Health-Related Quality of Life Burden of Overactive Bladder Using Disease-Specific Patient-Reported Outcome Measures: A Systematic Literature Review.Advances in therapy · 2019Pooled it
- Efficacy of transcutaneous electrical nerve stimulation combined with mirabegron therapy compared with mirabegron monotherapy for overactive bladder: a prospective randomized controlled study.World journal of urology · 2024Trial
- Radiofrequency as the New Opportunity in Treating Overactive Bladder and Urge Urinary Incontinence-A Single-Arm Pilot Study.Medicina (Kaunas, Lithuania) · 2024Trial
- Does metabolic syndrome influence the efficacy of mirabegron treatment in female patients with overactive bladder?International urogynecology journal · 2023Trial
- Phenotyping Overactive Bladder - Part 2: Can Management be Improved by Phenotyping, and Targeting Therapy According to Urgency Type and Other Characteristics? ICI-RS 2025.Neurourology and urodynamics · 2026Review
- Short-term cognitive effects of anticholinergics in patients with neurogenic lower urinary tract dysfunction: A systematic review and meta-analysis.Biomedical reports · 2025Article
- A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.Cureus · 2023Article
- Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults.The Cochrane database of systematic reviews · 2023Review
- Mirabegron in the Management of Overactive Bladder Syndrome.International journal of women's health · 2022Review
- Combination pharmacotherapy for the treatment of the overactive bladder syndrome: a new solution for an old problem?International urogynecology journal · 2020Article
- Factors Associated with Improvements in Patient-Reported Outcomes During Mirabegron or Antimuscarinic Treatment of Overactive Bladder Syndrome: A Registry Study (PERSPECTIVE).Advances in therapy · 2019Article
- βBritish journal of pharmacology · 2019Review
- Combination Pharmacotherapy for Treatment of Overactive Bladder (OAB).Current urology reports · 2019Review
- Meta-Analysis of the Efficacy and Safety of Mirabegron Add-On Therapy to Solifenacin for Overactive Bladder.International neurourology journal · 2017Article
- Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?International urogynecology journal · 2017Observational
- CUA guideline on adult overactive bladder.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2017Article
- Recent advances in pharmacological management of urinary incontinence.F1000Research · 2017Review
- Effects of different urodynamic characteristics on therapeutic outcomes of overactive bladder medication in a real-life clinical practice.Tzu chi medical journalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis large dose-ranging study explored the benefits of different combinations of mirabegron and solifenacin on health-related quality of life (HRQoL), based on patient-reported outcomes (PROs), and patients ('responders') achieving clinically meaningful improvements in efficacy and HRQoL.
methodsSYMPHONY (NCT01340027) was a Phase II, placebo- and monotherapy-controlled, dose-ranging, 12-week trial. Adult patients with overactive bladder (OAB) for ≥3 months were randomized to 1 of 12 groups: 6 combination (solifenacin 2.5/5/10 mg + mirabegron 25/50 mg), 5 monotherapy (solifenacin 2.5/5/10 mg, or mirabegron 25/50 mg), or placebo. Change from baseline to end of treatment was assessed, versus placebo and solifenacin 5 mg in: PROs (OAB-q [Symptom Bother/total HRQoL] and Patient Perception of Bladder Condition score), and responders achieving minimally important differences (MIDs) in PROs and predetermined clinically meaningful improvements in efficacy (e.g. <8 micturitions/24 h). Changes in PROs and responders were analysed using an ANCOVA model and logistic regression, respectively.
resultsThe Full Analysis Set included 1278 patients. Combination therapy of solifenacin 5/10 mg + mirabegron 25/50 mg significantly improved PROs versus solifenacin 5 mg and placebo, and significantly more responders achieved MIDs in PROs and efficacy. Micturition frequency normalization was approximately twofold greater with 10 + 25 mg (OR 2.06 [95 % CI 1.11, 3.84; p = 0.023]) and 5 + 50 mg (OR 1.91 [95 % CI 1.14, 3.21; p = 0.015]) versus solifenacin 5 mg.
conclusionCombining mirabegron 25/50 mg and solifenacin 5/10 mg improves objective and subjective efficacy outcomes compared with placebo or solifenacin 5 mg.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.