Evidence map›Paper›PMID 25539714›Full record

Trial reportTrials2014

Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.

Lois H Thomas, Caroline L Watkins, Christopher J Sutton, Denise Forshaw, Michael J Leathley, Beverley French, Christopher R Burton, Francine Cheater, Brenda Roe, David Britt and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

9 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
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  8. CONSORT 2010 statement: extension to randomised pilot and feasibility trials.Pilot and feasibility studies · 2016 · on this map
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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

13 authors at 6 institutions in 1 country.

Lois H ThomasSchool of Health, University of Central Lancashire, Victoria Street, Preston PR1 2HE, UK. lhthomas@uclan.ac.uk.
Caroline L Watkins
Christopher J Sutton
Denise Forshaw
Michael J Leathley
Beverley French
Christopher R Burton
Francine Cheater
Brenda Roe
David Britt
Joanne Booth
Elaine McColl
ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups
University of Lancashire · GBUniversity of East Anglia · GBUniversity of Liverpool · GBBangor University · GBGlasgow Caledonian University · GBNewcastle University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUrinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients.

methodsWe conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death.

resultsIt was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence.

conclusionsThe trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered.

trial registrationISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

Indexed as

Cognitive Behavioral TherapyAgedAged, 80 and overCognitionEnglandFeasibility StudiesFemaleHumansMaleOdds RatioPatient SelectionQuality of LifeRecovery of FunctionSample SizeStrokeTime Factors

Identifiers

PMID25539714
PMCPMC4307223
OpenAlexW2098237308

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.