Evidence map›Paper›PMID 40025238›Full record

Trial reportInternational urogynecology journal2025

A Randomized Controlled Trial of Instillation Protocols Prior to Intradetrusor OnabotulinumtoxinA.

Sarah A Ward, Annliz Macharia, Michele R Hacker, Eman A Elkadry, William D Winkelman

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International urogynecology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

5 authors.

Sarah A WardDepartment of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA, USA.
Annliz MachariaDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Michele R HackerDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Eman A ElkadryDepartment of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA, USA.
William D WinkelmanDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA. wwinkelm@bidmc.harvard.edu.ORCID 0000-0003-4445-6125

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
NCATS NIH HHS UL1 TR002541
6 · The paper itself

Abstract

introduction and hypothesisAchieving adequate pain relief is crucial for intradetrusor onabotulinumtoxinA treatments for idiopathic overactive bladder in office settings. The objective of this study was to determine whether buffered lidocaine bladder instillation provides better pain control than standard lidocaine prior to intradetrusor onabotulinumtoxinA injections.

methodsWe conducted a prospective, double-blind, randomized controlled trial comparing two protocols. The standard protocol used a pre-procedure instillation of 50 ml of 1% lidocaine and 50 ml of 0.9% saline. The buffered lidocaine protocol used 50 ml of 1% lidocaine, 45 ml of 0.9% saline, and 5 ml of 8.4% sodium bicarbonate. Both protocols were administered 20 min before onabotulinumtoxinA injections. Female patients with a primary diagnosis of idiopathic overactive bladder were randomized. The primary outcome was procedural pain using a visual analog scale (VAS) measured in millimeters, with secondary outcomes of patient satisfaction and willingness to repeat the procedure.

resultsOf the 76 patients enrolled, 38 were randomized to each group. Data were analyzed for 37 patients in the buffered lidocaine group, and 36 in the standard lidocaine group. Both groups had comparable baseline characteristics. There was no difference in median pain measured by VAS between the buffered (16 [9-40]) and standard (25 [15-55]) protocols (p = 0.21). The buffered group reported a higher, though not statistically significant, satisfaction rate (68% vs 39%, p = 0.08).

conclusionIntradetrusor onabotulinumtoxinA injections are generally well tolerated among women with idiopathic overactive bladder. No difference was found between protocols, suggesting that buffered lidocaine instillation may not improve pain control among women with idiopathic overactive bladder, although we had insufficient power to detect a difference of the observed magnitude.

Indexed as

Anesthetics, LocalBotulinum Toxins, Type ALidocaineProcedural PainUrinary Bladder, OveractiveAdministration, IntravesicalAdultAgedDouble-Blind MethodFemaleHumansMiddle AgedPain MeasurementPatient SatisfactionProspective StudiesSodium BicarbonateAnesthetics, LocalBotulinum Toxins, Type ALidocaineonabotulinum toxin ASodium BicarbonateBladder analgesiaBladder onabotulinumtoxinAIntradetrusor onabotulinumtoxinA injectionsOveractive bladder treatment

Identifiers

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Registered trials

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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.