Evidence map›Paper›PMID 40590342›Full record

Trial reportThe Journal of urology2025

The Efficacy and Safety Between Intradetrusor OnabotulinumtoxinA Injection and Combined Pharmacotherapy in Patients With Refractory Overactive Bladder: A Randomized Controlled Trial.

Meng-Hsuen Hsieh, Jiun-Chyi Hwang, Tsung-Hsien Su, Hui-Hsuan Lau

Registry-linked trialAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05968885 (Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05968885 phase4recruitingnot on this map

Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

TypeinterventionalSponsorMackay Memorial HospitalRan2021 to 2026Enrolled300ConditionsUrinary Bladder, Overactive, Urodynamics, Effect of DrugArmsIntradetrusor Botox® (onabotulinumtoxinA) injection, Combine Mirabegron and Solifenacin.
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Round up.Indian journal of urology : IJU : journal of the Urological Society of India
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Meng-Hsuen HsiehDepartment of Medicine, MacKay Medical College, New Taipei City, Taiwan.
Jiun-Chyi HwangDepartment of Medicine, MacKay Medical College, New Taipei City, Taiwan.
Tsung-Hsien SuDepartment of Medicine, MacKay Medical College, New Taipei City, Taiwan.
Hui-Hsuan LauDepartment of Medicine, MacKay Medical College, New Taipei City, Taiwan.ORCID 0000-0003-3620-9298

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe investigated whether intradetrusor onabotulinumtoxinA injection demonstrates superior efficacy and fewer side effects compared with combined pharmacotherapy in patients with refractory overactive bladder. MATERIALS AND

methodsIn this single-center, open-label, randomized trial, patients with urodynamically confirmed detrusor overactivity and persistent symptoms despite at least 2 months of single pharmacotherapy were randomized to receive onabotulinumtoxinA injection (100 U) or combined pharmacotherapy with solifenacin 5 mg and mirabegron 25 mg. Assessments at baseline and 12 weeks included voiding parameters, adverse events, and patient-reported outcomes using the Urogenital Distress Inventory, Incontinence Impact Questionnaire, and the Overactive Bladder Symptom Score.

resultsOf 74 patients enrolled, 66 completed the study (33 per group). Both treatments reduced urgency episodes to a median of 2.0 per 24 hours at 12 weeks. The mean difference between groups was -0.1 (95% CI: -1.5 to 1.4;

conclusionsBoth intradetrusor onabotulinumtoxinA and combined pharmacotherapy improved symptoms in women with refractory overactive bladder. OnabotulinumtoxinA demonstrated a more favorable safety profile and represents an appropriate option for patients sensitive to systemic anticholinergic effects or preferring nondaily interventions.

trial registrationClinicalTrials.gov Identifier: NCT05968885.

Indexed as

AcetanilidesBotulinum Toxins, Type AMuscarinic AntagonistsSolifenacin SuccinateThiazolesUrinary Bladder, OveractiveUrological AgentsAgedDrug Therapy, CombinationFemaleHumansMaleMiddle AgedTreatment OutcomeAcetanilidesBotulinum Toxins, Type AmirabegronMuscarinic Antagonistsonabotulinum toxin ASolifenacin SuccinateThiazolesUrological AgentsonabotulinumtoxinAoveractive bladderurgencyurinary incontinence

Identifiers

PMID40590342
PMCPMC12708037

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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.