Evidence map›Paper›PMID 32046754›Full record

ArticleTrials2020

Different electrode positioning for transcutaneous electrical nerve stimulation in the treatment of urgency in women: a study protocol for a randomized controlled clinical trial.

Juliana Falcão Padilha, Mariana Arias Avila, Enio Júnior Seidel, Patricia Driusso

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
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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

4 authors at 2 institutions in 1 country.

Juliana Falcão PadilhaPhysical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.ORCID http://orcid.org/0000-0002-7871-712X
Mariana Arias AvilaPhysical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.
Enio Júnior SeidelDepartment of Statistics, Federal University of Santa Maria (UFSM), Av Roraima 1000, Santa Maria, Rio Grande do Sul, CEP 97105-900, Brazil.
Patricia DriussoPhysical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil. pdriusso@ufscar.br.
Universidade Federal de São Carlos · BRUniversidade Federal de Santa Maria · BR

Funding

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Financing Code 001
6 · The paper itself

Abstract

backgroundUrgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inhibition, electrotherapy resources such as transcutaneous tibial nerve stimulation (TTNS) and parasacral transcutaneous electrical stimulation (PTES) have been used. The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques.

methodsThis randomized controlled clinical trial will include 99 women, aged more than 18 years old, with urgency (score ≥ 8 in the Overactive Bladder-Validated 8-Question Awareness Tool [OAB-V8]). Women will be randomly allocated into three groups: TTNS, PTES, and placebo. The following questionnaires will be applied: the Anamnesis Record, the Incontinence Questionnaire Overactive Bladder, the King's Health Questionnaire, the 24-Hour Voiding Diary, and the OAB-V8, at four different time points: at baseline prior to the first session, at the 6th session, the 12th session and at follow-up. The current used for the transcutaneous electrical stimulation will be a symmetrical balanced biphasic pulsed current, for 12 sessions, twice a week, for 20 minutes. Qualitative variables will be displayed as frequency and percentage, quantitative variables as mean and standard deviation. Comparison of urgency severity among groups will be performed with a repeated measures ANOVA, considering the effect of the three groups and the four evaluations, and interactions among them. DISCUSSION: The present study aims to contribute evidence for a more in-depth discussion on electrode positioning for electrostimulation used in urgency treatment. It should be emphasized that, based on the possibility of confirming the hypothesis that urgency will decrease in a similar way after both treatments (TTNS and PTES), the PTES will be used as an option for positioning the electrodes alternatively to the tibial nerve region in special populations, such as amputees or people with severe lower limb sensory impairment.

trial registrationBrazilian Registry of Clinical Trials (ReBEC) ID: RBR-9rf33n, date of registration: 17 May 2018.

Indexed as

AdultElectrodesFemaleFollow-Up StudiesHumansRandomized Controlled Trials as TopicSacrumSeverity of Illness IndexTibial NerveTranscutaneous Electric Nerve StimulationTreatment OutcomeUrinary BladderUrinary Bladder, OveractiveUrinary Incontinence, UrgeElectric stimulation therapyLower urinary tract symptomsOveractive urinary bladderTibial nerve

Identifiers

PMID32046754
PMCPMC7014940
OpenAlexW3011238668

What OpenQuestion holds

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LicenceCC BY
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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.