Evidence map›Paper›PMID 39797697›Full record

Trial reportBJU international2025

Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial.

Meryam El Issaoui, Marlene Elmelund, Niels Klarskov

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

Trial report in BJU international, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05415865 (The Effect of Intravesical Lidocaine Solution Versus Placebo as Anesthesia Prior to Intravesical Injection of Onabotulinum Toxin A. A Randomized, Double-blind, Placebo Controlled Cross-over Study), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT05415865 phase3unknown statusnot on this map

The Effect of Intravesical Lidocaine Solution Versus Placebo as Anesthesia Prior to Intravesical Injection of Onabotulinum Toxin A. A Randomized, Double-blind, Placebo Controlled Cross-over Study

TypeinterventionalSponsorHerlev and Gentofte HospitalRan2022 to 2024Enrolled50ConditionsUrge Incontinence, Overactive Bladder, Anesthesia, Local, Pain, ProceduralArmsAlkalinized Lidocaine, Placebo Sodium Chloride 0.9% Inj
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Meryam El IssaouiDepartment of Obstetrics and Gynecology, Herlev and Gentofte University Hospital, Herlev, Denmark.ORCID https://orcid.org/0000-0002-4570-7953
Marlene ElmelundDepartment of Gynecology and Obstetrics, Amager and Hvidovre Hospital, Hvidovre, Denmark.
Niels KlarskovDepartment of Obstetrics and Gynecology, Herlev and Gentofte University Hospital, Herlev, Denmark.

Funding

Herlev and Gentofte University Hospital Research Fund
6 · The paper itself

Abstract

objectivesTo evaluate the effect of intravesical alkalinised lidocaine as an anaesthetic treatment on procedural pain during intradetrusor onabotulinumtoxinA (BTX-A) injections for overactive bladder. PATIENTS AND

methodsThis single-centre, randomised, double-blind, placebo-controlled two period crossover trial was conducted on women scheduled for BTX-A injections at our outpatient urogynaecology clinic between September 2022 and May 2024. Patients were randomly assigned (1:1) to receive either alkalinised lidocaine or placebo during the first treatment period. Alkalinised lidocaine solution comprised lidocaine hydrochloride (20 mg/mL, 20 mL), sodium hydrogen carbonate (1 mmoL/mL, 10 mL), and sodium chloride (9 g/L, 10 mL). The matching placebo was sodium chloride (9 g/L, 40 mL). The primary outcome measure was procedural pain rated on a 100-mm visual analogue scale (VAS). Secondary outcomes included adverse effects such as post-void residual urine volumes requiring catheterisation, urinary tract infection, haematuria 1 week after treatment, and patient satisfaction measured on a 5-point scale. During the second treatment period, patients received the alternative intervention.

resultsWe enrolled 50 patients, of which 41 were eligible for per-protocol analyses. The mean VAS score was significantly lower following intravesical alkalinised lidocaine (mean 21.3 mm, 95% confidence interval [CI] 14.7-27.8 mm) compared to placebo (mean 41.6 mm, 95% CI 35.0-48.1 mm) with a mean difference of -20.3 mm (95% CI -29.2 to -11.5 mm; P < 0.001). Adverse events and patient satisfaction did not significantly differ between the alkalinised lidocaine and placebo treatments (P = 0.825 and P = 0.138, respectively).

conclusionsIntravesical instillation of alkalinised lidocaine before BTX-A injections significantly reduced VAS pain scores compared to placebo (ClinicalTrials.gov identifier: NCT05415865).

Indexed as

Anesthetics, LocalBotulinum Toxins, Type ALidocaineProcedural PainUrinary Bladder, OveractiveAdministration, IntravesicalAdultAgedCross-Over StudiesDouble-Blind MethodFemaleHumansMiddle AgedPain MeasurementAnesthetics, LocalBotulinum Toxins, Type ALidocaineonabotulinum toxin Aalkalinised lidocainecrossover studyintravesical administrationlocal anaestheticsonabotulinumtoxinAoveractive bladder syndromepainrandomised controlled trialvisual analogue scale

Identifiers

PMID39797697
PMCPMC11913603

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.