ELECtric Tibial nerve stimulation to Reduce Incontinence in Care Homes: protocol for the ELECTRIC randomised trial

Jo Booth, Lorna Aucott, Seonaidh Cotton, Claire Goodman, Suzanne Hagen, Danielle Harari, Maggie Lawrence, Andy Lowndes, Lisa Macaulay, Graeme Maclennan, Helen Mason, Doreen McClurg, John Norrie, Christine Norton, Catriona O'Dolan, Dawn Skelton, Clare Surr, Shaun Treweek

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Abstract

Background
Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CH) and profoundly impacts on residents’ dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in care homes is not known. The ELECTRIC Trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in care home residents and investigate the associated costs and consequences.

Methods
This is a pragmatic, multicentre, placebo controlled randomised parallel group trial comparing effectiveness of TPTNS (target n=250) with sham stimulation (target n=250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff- reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-hour pad weight tests (PWT), post void residual urine (bladder scans), Patient Perception of Bladder Condition (PPBC), Minnesota Toileting Skills Questionnaire (MTSQ) and Dementia Quality of Life (DEMQOL). Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers.

Discussion
TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC Trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication.

Trial registration
Clinical Trials.gov. NCT03248362. Registered on 14/08/2017. https://clinicaltrials.gov/
ISRCTN, ISRCTN 98415244. Registered on 25/04/2018. https://www.isrctn.com/
Original languageEnglish
Article number723
Number of pages14
JournalTrials
Volume20
DOIs
Publication statusPublished - 16 Dec 2019

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Tibial Nerve
Home Care Services
Costs and Cost Analysis
Absorbent Pads
Urinary Bladder
Quality of Life
Random Allocation
Nursing Care
Cost-Benefit Analysis
Dementia
Placebos
Urine
Interviews
Weights and Measures

Keywords

  • care homes
  • nursing home
  • urinary incontinence
  • tibial nerve stimulation
  • older adults

Cite this

Booth, Jo ; Aucott, Lorna ; Cotton, Seonaidh ; Goodman, Claire ; Hagen, Suzanne ; Harari, Danielle ; Lawrence, Maggie ; Lowndes, Andy ; Macaulay, Lisa ; Maclennan, Graeme ; Mason, Helen ; McClurg, Doreen ; Norrie, John ; Norton, Christine ; O'Dolan, Catriona ; Skelton, Dawn ; Surr, Clare ; Treweek, Shaun. / ELECtric Tibial nerve stimulation to Reduce Incontinence in Care Homes: protocol for the ELECTRIC randomised trial. In: Trials. 2019 ; Vol. 20.
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ELECtric Tibial nerve stimulation to Reduce Incontinence in Care Homes: protocol for the ELECTRIC randomised trial. / Booth, Jo; Aucott, Lorna; Cotton, Seonaidh; Goodman, Claire; Hagen, Suzanne; Harari, Danielle; Lawrence, Maggie; Lowndes, Andy; Macaulay, Lisa; Maclennan, Graeme; Mason, Helen; McClurg, Doreen; Norrie, John; Norton, Christine; O'Dolan, Catriona; Skelton, Dawn; Surr, Clare; Treweek, Shaun.

In: Trials, Vol. 20, 723, 16.12.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - ELECtric Tibial nerve stimulation to Reduce Incontinence in Care Homes: protocol for the ELECTRIC randomised trial

AU - Booth, Jo

AU - Aucott, Lorna

AU - Cotton, Seonaidh

AU - Goodman, Claire

AU - Hagen, Suzanne

AU - Harari, Danielle

AU - Lawrence, Maggie

AU - Lowndes, Andy

AU - Macaulay, Lisa

AU - Maclennan, Graeme

AU - Mason, Helen

AU - McClurg, Doreen

AU - Norrie, John

AU - Norton, Christine

AU - O'Dolan, Catriona

AU - Skelton, Dawn

AU - Surr, Clare

AU - Treweek, Shaun

N1 - Acceptance in SAN/ from webpage OA article

PY - 2019/12/16

Y1 - 2019/12/16

N2 - BackgroundUrinary incontinence (UI) is highly prevalent in nursing and residential care homes (CH) and profoundly impacts on residents’ dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in care homes is not known. The ELECTRIC Trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in care home residents and investigate the associated costs and consequences.MethodsThis is a pragmatic, multicentre, placebo controlled randomised parallel group trial comparing effectiveness of TPTNS (target n=250) with sham stimulation (target n=250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff- reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-hour pad weight tests (PWT), post void residual urine (bladder scans), Patient Perception of Bladder Condition (PPBC), Minnesota Toileting Skills Questionnaire (MTSQ) and Dementia Quality of Life (DEMQOL). Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers.DiscussionTPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC Trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication.Trial registrationClinical Trials.gov. NCT03248362. Registered on 14/08/2017. https://clinicaltrials.gov/ISRCTN, ISRCTN 98415244. Registered on 25/04/2018. https://www.isrctn.com/

AB - BackgroundUrinary incontinence (UI) is highly prevalent in nursing and residential care homes (CH) and profoundly impacts on residents’ dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in care homes is not known. The ELECTRIC Trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in care home residents and investigate the associated costs and consequences.MethodsThis is a pragmatic, multicentre, placebo controlled randomised parallel group trial comparing effectiveness of TPTNS (target n=250) with sham stimulation (target n=250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff- reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-hour pad weight tests (PWT), post void residual urine (bladder scans), Patient Perception of Bladder Condition (PPBC), Minnesota Toileting Skills Questionnaire (MTSQ) and Dementia Quality of Life (DEMQOL). Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers.DiscussionTPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC Trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication.Trial registrationClinical Trials.gov. NCT03248362. Registered on 14/08/2017. https://clinicaltrials.gov/ISRCTN, ISRCTN 98415244. Registered on 25/04/2018. https://www.isrctn.com/

KW - care homes

KW - nursing home

KW - urinary incontinence

KW - tibial nerve stimulation

KW - older adults

U2 - 10.1186/s13063-019-3723-7

DO - 10.1186/s13063-019-3723-7

M3 - Article

VL - 20

M1 - 723

ER -