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Published in: Trials 1/2014

Open Access 01-12-2014 | Research

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

Authors: 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, Joanne Booth, Elaine McColl, The ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups

Published in: Trials | Issue 1/2014

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Abstract

Background

Urinary 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.

Methods

We 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.

Results

It 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.

Conclusions

The 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 registration

ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.
Appendix
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Literature
1.
Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe , CDA: Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001, 32: 1279-1284. 10.1161/01.STR.32.6.1279.CrossRefPubMed
2.
Kolominsky-Rabas PL, Hilz MJ, Neundoerfer B, Heuschmann PU: Impact of urinary incontinence after stroke: results from a prospective population-based stroke register. Neurourol Urodyn. 2003, 22: 322-327. 10.1002/nau.10114.CrossRefPubMed
3.
Williams MP, Srikanth V, Bird M, Thrift AG: Urinary symptoms and natural history of urinary continence after first-ever stroke–a longitudinal population-based study. Age Ageing. 2012, 41: 371-376. 10.1093/ageing/afs009.CrossRefPubMed
4.
Jorgensen L, Engstad T, Jacobsen BK: Self-reported urinary incontinence in noninstitutionalized long-term stroke survivors: A population-based study. Arch Phys Med Rehabil. 2005, 86: 416-420. 10.1016/j.apmr.2004.05.011.CrossRefPubMed
5.
Party ISW: National Clinical Guideline for Stroke. 2012, London: Royal College of Physicians, 4
6.
Party ISW: National Sentinel Stroke Audit 2010. 2011, London: Royal College of Physicians
7.
Booth J, Kumlien S, Zang Y, Gustafsson B, Tolson D: Rehabilitation nurses practices in relation to urinary incontinence following stroke: a cross-cultural comparison. J Clin Nurs. 2009, 18: 1049-1058. 10.1111/j.1365-2702.2008.02688.x.CrossRefPubMed
8.
Jordan LA, Mackey E, Coughlan K, Wyer M, Allnutt N, Middleton S: Continence management in acute stroke: a survey of current practices in Australia. J Adv Nurs. 2011, 67: 94-104. 10.1111/j.1365-2648.2010.05480.x.CrossRefPubMed
9.
Thomas LH, Cross S, Barrett J, French B, Leathley M, Sutton CJ, Watkins C: Treatment of urinary incontinence after stroke in adults. Cochrane Database Syst Rev. 2008, Art. No.: CD004462-doi:10.1002/14651858.CD004462.pub3, Issue 1
10.
Eustice S, Roe B, Paterson J: Prompted voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2000, Art. No.: CD002113-doi:10.1002/14651858.CD002113, Issue 2
11.
Dumoulin C, Hay-Smith EJC, Mac Habée-Séguin G: Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014, Art. No.: CD005654-doi:10.1002/14651858.CD005654.pub3, Issue 5
12.
Wallace SA, Roe B, Williams K, Palmer M: Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev. 2004, Art. No.: CD001308-doi:10.1002/14651858.CD001308.pub2, Issue 1
13.
Thomas LH, Watkins CL, French B, Sutton C, Forshaw D, Cheater F, Roe B, Leathley MJ, Burton C, McColl E, Booth J: The ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups: Study protocol: ICONS: Identifying continence options after stroke: a randomised trial. Trials. 2011, 12: 131-10.1186/1745-6215-12-131.CrossRefPubMedPubMedCentral
14.
Party ISW: National Sentinel Stroke Audit. Organisational Audit 2009. 2010, London: Royal College of Physicians
15.
Goldstein M, Barnett HJM, Orgogozo JM, Sartorius N, Symon L, Vereshchagin NV: Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and Other Cerebrovascular Disorders. Stroke. 1989, 20: 1407-1431.CrossRef
16.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A: The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002, 21: 167-178. 10.1002/nau.10052.CrossRefPubMed
17.
Shaw C, Matthews RJ, Perry SI, Assassa RP, Williams K, McGrother C, Dallosso H, Jagger C, Mayne C, Clarke M, Leicestershire MRC Incontinence Study Team: Validity and reliability of an interviewer-administered questionnaire to measure the severity of lower urinary tract symptoms of storage abnormality: the Leicester Urinary Symptom Questionnaire. BJU Int. 2002, 90: 205-215. 10.1046/j.1464-410X.2002.02893.x.CrossRefPubMed
18.
Department of Health: Attributing the Cost of Health and Social Care Research & Development (AcoRD). 2012, London: Department of Health
19.
Martin JL, Williams KS, Abrams KR, Turner DA, Sutton AJ, Chapple C, Assassa RP, Shaw C, Cheater F: Systematic review and evaluation of methods of assessing urinary incontinence. Health Technol Assess. 2006, 10: 1-132.CrossRefPubMed
20.
Wyman JF, Fantl JA, McClish DK, Bump RC: Comparative efficacy of behavioral interventions in the management of female urinary incontinence. Continence Program for Women Research Group. Am J Obstet Gynecol. 1998, 179: 999-1007. 10.1016/S0002-9378(98)70206-6.CrossRefPubMed
21.
Milani R, Scalambrino S, Carrera S, Quadri G, Riva D, Casolati E: A randomised trial of bladder retraining versus oxybutynin in the treatment of idiophatic urge syndrome: early results. Proceedings of the International Continence Society, 16th Annual Meeting; Sept 17–19; Boston, Massachusetts. 1986, Boston, 488-490.
22.
Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K: The effect of behavioral therapy on urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2002, 100: 72-78. 10.1016/S0029-7844(02)01993-2.PubMed
23.
Lentz G, Plevnik S, Stanton SL: Vaginal cones versus bladder drill for sensory urgency treatment. Proceedings of the International Continence Society (ICS), 24th Annual Meeting; Prague. 1994, 35-36.
24.
Ostaszkiewicz J, Eustice S, Roe B, Thomas LH, French B, Islam T, O’Connell B, Cody JD: Toileting assistance programmes for the management of urinary incontinence in adults (Protocol). Cochrane Database Syst Rev. 2013, CD010589
25.
O’Donnell PD: Behavioral modification for institutionalized individuals with urinary incontinence. Urology. 1998, 51 (Suppl 2A): 40-42.CrossRefPubMed
26.
Cheater FM, Baker R, Reddish S, Spiers N, Wailoo A, Gillies C, Robertson N, Cawood C: Cluster randomized controlled trial of the effectiveness of audit and feedback and educational outreach on improving nursing practice and patient outcomes. [see comment]. Medical Care. 2006, 44: 542-551. 10.1097/01.mlr.0000215919.89893.8a.CrossRefPubMed
27.
Harvey G, Loftus-Hills A, Rycroft-Malone J, Titchen A, Kitson A, McCormack B, Seers K: Getting evidence into practice: the role and function of facilitation. J Adv Nurs. 2002, 37: 577-588. 10.1046/j.1365-2648.2002.02126.x.CrossRefPubMed
28.
Seers K, Cox K, Crichton NJ, Edwards RT, Eldh AC, Estabrooks CA, Harvey G, Hawkes C, Kitson A, Linck P, McCarthy G, McCormack B, Mockford C, Rycroft-Malone J, Titchen A, Wallin L: FIRE (Facilitating Implementation of Research Evidence): a study protocol. Implement Sci. 2012, 7: 25-10.1186/1748-5908-7-25.CrossRefPubMedPubMedCentral
29.
Stetler CB, Legro MW, Rycroft-Malone J, Bowman C, Curran G, Guihan M, Hagedorn H, Pineros S, Wallace CM: Role of “external facilitation” in implementation of research findings: a qualitative evaluation of facilitation experiences in the Veterans Health Administration. Implement Sci. 2006, 1: 23-10.1186/1748-5908-1-23.CrossRefPubMedPubMedCentral
30.
Loftus-Hills A, Harvey G: A Review of the Role of Facilitators in Changing Professional Health Care Practice. 2000, Oxford: RCN Institute
31.
Bamford J, Sandercock P, Dennis M, Burn J, Warlow C: Classification and natural history of clinically identifiable subtypes of cerebral infarction. Lancet. 1991, 337: 1521-1526. 10.1016/0140-6736(91)93206-O.CrossRefPubMed
32.
Collin C, Wade DT, Davies S, Horne V: The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988, 10: 61-63. 10.3109/09638288809164103.CrossRefPubMed
33.
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J: Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988, 19: 604-607. 10.1161/01.STR.19.5.604.CrossRefPubMed
34.
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H: Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983, 140: 734-739.CrossRefPubMed
35.
Teasdale G, Jennett B: Assessment and prognosis of coma after head injury. Acta Neurochir (Wien). 1976, 34: 45-55. 10.1007/BF01405862.CrossRef
36.
Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P: ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004, 23: 322-330. 10.1002/nau.20041.CrossRefPubMed
37.
Sandvik H, Espuna M, Hunskaar S: Validity of the incontinence severity index: comparison with pad-weighing tests. Int Urogynecol J Pelvic Floor Dysfunct. 2006, 17: 520-524. 10.1007/s00192-005-0060-z.CrossRefPubMed
38.
The EuroQol Group: EuroQol--a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990, 16: 199-208.CrossRef
39.
Counsell C, Dennis M, McDowall M, Warlow C: Predicting outcome after acute and subacute stroke: development and validation of new prognostic models. Stroke. 2002, 33: 1041-1047. 10.1161/hs0402.105909.CrossRefPubMed
40.
Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP: Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999, 53: 71-76. 10.1016/S0090-4295(98)00454-3.CrossRefPubMed
41.
Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP: Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996, 47: 67-71. 10.1016/S0090-4295(99)80384-7.CrossRefPubMed
42.
Taljaard M, Donner A, Klar N: Imputation strategies for missing continuous outcomes in cluster randomized trials. Biom J. 2008, 50: 329-345. 10.1002/bimj.200710423.CrossRefPubMed
43.
Barrett JA: Bladder and bowel problems after stroke. Rev Clin Gerontol. 2002, 12: 253-267.CrossRef
44.
45.
Dumoulin C, Korner-Bitensky N, Tannenbaum C: Urinary incontinence after stroke: does rehabilitation make a difference? A systematic review of the effectiveness of behavioral therapy. Topic Stroke Rehabil. 2005, 12: 66-76. 10.1310/ENMX-RUV5-15WL-VNA2.CrossRef
46.
Wikander B, Ekelund P, Milsom I: An evaluation of multidisciplinary intervention governed by functional independence measure (FIMSM) in incontinent stroke patients. Scand J Rehabil Med. 1998, 30: 15-21. 10.1080/003655098444273.CrossRefPubMed
47.
Tibaek S, Gard G, Jensen R: Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodynamics. 2005, 24: 348-357. 10.1002/nau.20134.CrossRef
48.
Abrams P, Cardozo L, Khoury S, Wein A: Incontinence: 4th International Consultation on Incontinence. 2009, London: Health Publications Ltd
Metadata
Title
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial
Authors
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
Joanne Booth
Elaine McColl
The ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-509

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