Evidence map›Paper›PMID 39836173›Full record

Trial reportInternational urogynecology journal2025

Onabotulinum Toxin A-Led Urinary Tract Infections-Should we Safeguard? A Randomized Controlled Trial.

Anastasiya Holubyeva, Kaythi Khin, Tess Gao, Shaun Adair, Erika Wasenda, Laura Dhariwal, Ricardo Caraballo, Svjetlana Lozo, John Rutledge, Carolyn Botros

Abstract readRandomized Controlled TrialMulticenter Study
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. 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.

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

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

10 authors.

Anastasiya HolubyevaDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA. a.holubyeva@gmail.com.ORCID 0009-0000-3612-9867
Kaythi KhinDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.
Tess GaoDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.
Shaun AdairDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.
Erika WasendaDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.
Laura DhariwalDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.
Ricardo CaraballoDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.
Svjetlana LozoDepartment of Urogynecology and Reconstructive Pelvic Surgery, Columbia University, New York, NY, USA.
John RutledgeDepartment of Biostatistics, Atlantic Center for Research, Morristown, NJ, USA.
Carolyn BotrosDepartment of Urogynecology and Reconstructive Pelvic Surgery, Atlantic Health System, 435 South Street, Suite 370, Morristown, NJ, 07960, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisThe objective of our study was to evaluate the need for antibiotic prophylaxis for urinary tract infection (UTI) prevention before Onabotulinum toxin A injection for overactive bladder (OAB). We hypothesize that the lack of antibiotic prophylaxis might not be inferior to administering prophylaxis.

methodsThis was a multi-centered, nonblinded, randomized controlled trial conducted between August 2022 and September 2024. Participants were randomized to either receive oral antibiotics or no treatment. Our primary outcome was to measure the rate of UTI at 2 weeks. Our secondary outcomes included post-void residuals, assessment for antibiotic compliance, and UTI rates at 6 weeks. Given a 20% UTI rate and a delta of 20%, 64 participants per study arm were necessary to achieve 80% power with an alpha value of 0.05.

resultsRates of UTI at 2 weeks post-procedure were 9.2% in the antibiotics group and 10.9% in the control group (p = 0.75). UTI rates 6 weeks post-procedure were 4.7% in the antibiotics group and 11.1% in the control group (p = 0.21). When analyzing variables such as age, race, body mass index, menopause status, vaginal estrogen use, or the rates of positive pre-procedure urine cultures, no factors proved to be predictors of developing a UTI at 2 weeks post-procedure. The urinary retention rate in our study was 0.8%.

conclusionsRates of UTI were not significantly different between patients who obtained antibiotics prophylaxis and those who did not at 2 and 6 weeks following injection. Foregoing antibiotics prophylaxis in order to safeguard from the dangers of antimicrobial resistance may be considered in the treatment of OAB with Onabotulinum toxin A.

Indexed as

Anti-Bacterial AgentsAntibiotic ProphylaxisBotulinum Toxins, Type AUrinary Bladder, OveractiveUrinary Tract InfectionsAdultAgedFemaleHumansMiddle AgedAnti-Bacterial AgentsBotulinum Toxins, Type Aonabotulinum toxin AAntibiotics resistanceOnabotulinum toxin AOveractive bladderUrinary tract infections

Identifiers

PMID39836173

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.