Evidence map›Paper›PMID 25839382›Full record

ArticleThe Journal of urology2015

Intravesical Liposomal Tacrolimus Protects against Radiation Cystitis Induced by 3-Beam Targeted Bladder Radiation.

Bharathi Raja Rajaganapathy, Joseph J Janicki, Peter Levanovich, Pradeep Tyagi, Jason Hafron, Michael B Chancellor, Sarah Krueger, Brian Marples

Open access · greenAbstract read
In one paragraph

Article in The Journal of urology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
5.3field-weighted citation impact, top 4% of its field
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

29 citing papers in PubMed, 49 citations in OpenAlex.

  1. Trial
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  10. Radiation-induced skin injury in the head and neck region: pathogenesis, clinics, prevention, treatment considerations and proposal for management algorithm.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
    Review
  11. Prevention of Radiation-Induced Bladder Injury: A Murine Study Using Captopril.International journal of radiation oncology, biology, physics · 2023
    Article
  12. Review
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  14. Modeling normal bladder injury after radiation therapy.International journal of radiation biology · 2023
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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

8 authors at 3 institutions in 1 country.

Bharathi Raja RajaganapathyDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Joseph J JanickiDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Peter LevanovichDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Pradeep TyagiDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Jason HafronDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Michael B ChancellorDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania. Electronic address: chancellormb@gmail.com.
Sarah KruegerDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Brian MarplesDepartments of Urology and Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan; Lipella Pharmaceuticals, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Lipella Pharmaceuticals (United States) · USOakland University · USUniversity of Pittsburgh · US

Funding

Preclinical Development of Tacrolimus for Radiation CystitisR44DK102247 · NIDDK · LIPELLA PHARMACEUTICALS, INC. · PI KAUFMAN, JONATHAN H · 2014 to 2016
$1.5M
Clinical Development of Tacrolimus for Hemorrhagic CystitisSB1DK102247 · NIDDK · LIPELLA PHARMACEUTICALS, INC. · PI KAUFMAN, JONATHAN H · 2017 to 2018
$998k
NIDDK NIH HHS R44 DK102247NIDDK NIH HHS R44DK102247NIDDK NIH HHS SB1 DK102247
6 · The paper itself

Abstract

purposeWe primarily determined whether the small animal radiation research platform could create a rat radiation cystitis model via targeted bladder irradiation (phase I). The response to treating early phase radiation cystitis in rats with transurethral catheter instillation of liposomal tacrolimus was also examined (phase II). MATERIALS AND

methodsIn phase I 16 adult female Sprague Dawley® rats were used. Metabolic urination patterns were analyzed before and after exposure to 20, 30 or 40 Gy radiation. In phase II irradiated rats were randomly assigned to receive a single instillation of saline or liposomal tacrolimus.

resultsThe 40 Gy radiation dose induced statistically significant reductions in the intermicturition interval compared to the lower radiation doses. By approximately 20 minutes 40 Gy radiation caused a significant decrease in the mean intermicturition interval (p < 0.0001). Histological analysis revealed degenerative epithelial changes and urothelial swelling with evidence of pseudocarcinomatous epithelial hyperplasia. Therefore, 40 Gy were chosen for the phase II efficacy study. There was no measurable change in total voided urine volume after irradiation, or after liposomal tacrolimus or saline instillation. Liposomal tacrolimus significantly increased the post-irradiation intermicturition interval by approximately 30 minutes back to baseline (p < 0.001).

conclusionsThe radiation cystitis rat model showed a dose dependent decrease in the intermicturition interval without inducing short-term skin or gastrointestinal damage. This study demonstrates that liposomal tacrolimus may be a promising new intravesical therapy for the rare, serious condition of radiation cystitis.

Indexed as

Administration, IntravesicalAnimalsCystitisDose-Response Relationship, DrugDose-Response Relationship, RadiationFemaleImmunosuppressive AgentsInstillation, DrugNeoplasms, ExperimentalPelvic NeoplasmsProtective AgentsRadiation Injuries, ExperimentalRatsRats, Sprague-DawleyTacrolimusTreatment OutcomeImmunosuppressive AgentsProtective AgentsTacrolimusabnormalitiesanimalcystitismodelsradiation-inducedtacrolimusurinary bladder

Identifiers

PMID25839382
PMCPMC4509800
OpenAlexW2141043078

What OpenQuestion holds

Textmetadata
LicenceTDM
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.