Evidence map›Paper›PMID 40075319›Full record

Observational studyBMC urology2025

Factors predicting local or systemic side effects related to intravesical BCG (Bacillus Calmette-Guérin) therapy: a retrospective observational study.

Tugay Aksakalli, Adem Utlu, Feyzullah Celik, Ahmet Emre Cinislioglu, Saban Oguz Demirdogen, Muhittin Atar, Ibrahim Karabulut

Abstract readObservational Study
In one paragraph

Observational study in BMC urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

7 authors.

Tugay AksakalliDepartment of Urology, University of Health Sciences, Erzurum Regional Training and Research Hospital, Erzurum, Turkey. tugay_daydreamer@hotmail.com.
Adem UtluDepartment of Urology, University of Health Sciences, Erzurum Regional Training and Research Hospital, Erzurum, Turkey.
Feyzullah CelikDepartment of Urology, University of Health Sciences, Erzurum Regional Training and Research Hospital, Erzurum, Turkey.
Ahmet Emre CinisliogluDepartment of Urology, University of Health Sciences, Erzurum Regional Training and Research Hospital, Erzurum, Turkey.
Saban Oguz DemirdogenDepartment of Urology, Ataturk University Medical Faculty, Erzurum, Turkey.
Muhittin AtarDepartment of Urology, University of Health Sciences, Erzurum Regional Training and Research Hospital, Erzurum, Turkey.
Ibrahim KarabulutDepartment of Urology, University of Health Sciences, Erzurum Regional Training and Research Hospital, Erzurum, Turkey.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIntravesical BCG treatment is the most frequently preferred adjuvant treatment option with its effective results in non-muscle invasive bladder tumors. Despite effective results, systemic and local side effects can be observed and can be one of the main reasons for treatment discontinuation. In this study we aimed to identify clinical factors predicting BCG-related side effects during intravesical BCG therapy in patients with non-muscle invasive bladder cancer.

methodsDemographic and clinical data of patients who received intravesical adjuvant BCG therapy for non-muscle invasive bladder tumor were obtained from patient records. Data on side effects following intravesical BCG therapy and clinical approaches were collected. After creating the patient sample, binary logistic regression analysis was performed to identify parameters and independent risk factors predicting BCG-related side effects, and to evaluate data related to the clinical management of BCG-related side effects.

resultsAmong the 276 patients included in the study, 23(8.3%) developed BCG-related local and systemic side effects. The mean IPSS(13.5 ± 2.9 vs. 17.6 ± 1.7) and mean tumor size(2.5 ± 0.9 vs. 3.6 ± 1.0 cm)were significantly higher in the group with BCG-related side effects(p < 0.001). The rate of CIS was significantly higher in the group with BCG-related side effects(21.7% vs. 3.9%,p = 0.004). Local side effects included cystitis symptoms in 18(78.2%) patients and epididymo-orchitis in 2(8.6%) patients. Systemic side effects included malaise and fever below 38.5 °C in 4(17.3%) patients, and fever above 38.5 °C lasting longer than 48 h in 2(8.6%) patients. Logistic regression analysis identified IPSS, tumor size, and the presence of CIS as independent risk factors.

conclusionHigh IPSS, large tumor size, and the presence of CIS were significant predictors of side effects during intravesical BCG therapy. Clinicians can ensure more effective use of BCG by preventing treatment discontinuation through approaches such as the use of quinolones and dose reduction in patients with these factors.

Indexed as

Adjuvants, ImmunologicBCG VaccineUrinary Bladder NeoplasmsAdministration, IntravesicalAgedAged, 80 and overFemaleHumansMaleMiddle AgedRetrospective StudiesRisk FactorsAdjuvants, ImmunologicBCG VaccineBCG-Related side effectsIndependent risk factorsIntravesical BCG therapyNon-Muscle invasive bladder Cancer

Identifiers

PMID40075319
PMCPMC11900595

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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.