Evidence map›Paper›PMID 35780464›Full record

ArticleInternational urology and nephrology2022

Intravesical sustained release system of lidocaine and oxybutynin results from in vitro and animal study.

David Dothan, Galiya Raisin, Nadav Malchi, Avi Gordon, Dan Touitou, Boris Chertin

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In one paragraph

Article in International urology and nephrology, 2022. 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
1.3field-weighted citation impact, top 21% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
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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

6 authors at 1 institution in 1 country.

David DothanThe Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University, 91031, Jerusalem, Israel.
Galiya RaisinThe Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University, 91031, Jerusalem, Israel.
Nadav MalchiThe Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University, 91031, Jerusalem, Israel.
Avi GordonThe Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University, 91031, Jerusalem, Israel.
Dan TouitouThe Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University, 91031, Jerusalem, Israel.
Boris ChertinThe Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University, 91031, Jerusalem, Israel. boris.chertin@gmail.com.ORCID http://orcid.org/0000-0002-8347-0969
Shaare Zedek Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInterstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic debilitating condition of unknown etiology. Intravesical lidocaine demonstrated pain relief in patients with IC/BPS. Intravesical oxybutynin has shown therapeutic efficacy in patients with urinary bladder disorders. However, loss of drug with urination requiring multiple administrations and immediate dilution of drug concentration by residual urine in the bladder mitigated intravesical use of both drugs in clinical practice. The aim of this study was to evaluate the efficacy and safety of fixed-dose combination of lidocaine and oxybutynin, forming in the urine a sustained delivery system named TRG-042. MATERIAL AND

methodsIn-vitro, we have quantitatively tested the concentration of lidocaine and oxybutynin released from TRG-042 in artificial urine. Following the successful in-vitro study weekly formulation of TRG-042 was instilled intravesically to six pigs. All pigs were followed with cystoscopy to assess the gradual degradation of the delivery system and to evaluate bladder response over 7 days. Daily blood samples were tested for drug quantization.

resultsIn-vitro studies have demonstrated oxybutynin and lidocaine sustained release over 1-week period coupled with full degradation of the matrix. None of the animals demonstrated any side effects following instillation. Cystoscopy examination observed gradual disintegration of TRG-042 over 1-week with no adverse reaction to the mucosa. Plasma concentrations of oxybutynin and lidocaine were uniformly stable over the 1-week period [1.46 ± 0.176 ng/ml and 4.29 ± 2.48 ng/ml respectively(mean ± SEM)] with almost undetectable concentration of N-desethyloxybutynin (NDO)[0.032 ± 0.068 ng/ml].

conclusionsThe in-vitro and animal data demonstrated that TRG-042 can safely be used for intravesical sustained release of lidocaine and oxybutynin in the treatment of BPS/IC.

Indexed as

Cystitis, InterstitialLidocaineAdministration, IntravesicalAnimalsDelayed-Action PreparationsMandelic AcidsSwineDelayed-Action PreparationsLidocaineMandelic AcidsoxybutyninBladder pain syndromeInterstitial CystitisLidocaineOxybutyninSustained releaseTRG-042

Identifiers

PMID35780464
OpenAlexW4283789087

What OpenQuestion holds

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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.