Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT

Joanne Booth; Lorna Aucott; Seonaidh Cotton; Bridget Davis; Linda Fenocchi; Claire Goodman; Suzanne Hagen; Danielle Harari; Maggie Lawrence; Andrew Lowndes; Lisa Macaulay; Graeme MacLennan; Helen Mason; Doreen McClurg; John Norrie; Christine Norton; Catriona O'Dolan; Dawn Skelton; Claire Surr; Shaun Treweek

doi:10.3310/hta25410

Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT

Joanne Booth
, Lorna Aucott
, Seonaidh Cotton
, Bridget Davis
, Linda Fenocchi
, Claire Goodman
, Suzanne Hagen
, Danielle Harari
, Maggie Lawrence
, Andrew Lowndes
, Lisa Macaulay
, Graeme MacLennan
, Helen Mason
, Doreen McClurg
, John Norrie
, Christine Norton
, Catriona O'Dolan
, Dawn Skelton
, Claire Surr
, Shaun Treweek

King's College London

Glasgow Caledonian University
University of Aberdeen
University of Hertfordshire
Department of Geriatric Medicine
GSTT Guy's and St Thomas' NHS Foundation Trust
Health Services Research Unit
University of Edinburgh
King's College London
Leeds Beckett University

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

Abstract

Background: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. Objective: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. Design: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. Setting: A total of 37 UK residential and nursing care homes. Participants: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Interventions: Residents were randomised (1: 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Main outcome measures: Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. Result: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation,n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. Conclusions: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context.

Original language	English
Pages (from-to)	1-109
Number of pages	109
Journal	Health technology assessment (Winchester, England)
Volume	25
Issue number	41
DOIs	https://doi.org/10.3310/hta25410
Publication status	Published - 1 Jun 2021

Keywords

ABSORBENT PADS
COGNITION
COST–CONSEQUENCE ANALYSIS
ELECTRIC STIMULATION
FRAIL ELDERLY
NURSING HOMES
RANDOMISED CONTROLLED TRIAL
TIBIAL NERVE
URINARY INCONTINENCE

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10.3310/hta25410

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Booth, J., Aucott, L., Cotton, S., Davis, B., Fenocchi, L., Goodman, C., Hagen, S., Harari, D., Lawrence, M., Lowndes, A., Macaulay, L., MacLennan, G., Mason, H., McClurg, D., Norrie, J., Norton, C., O'Dolan, C., Skelton, D., Surr, C., & Treweek, S. (2021). Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT. Health technology assessment (Winchester, England), 25(41), 1-109. https://doi.org/10.3310/hta25410

@article{0b1577f613de4bc099d482aab8d33da8,

title = "Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT",

abstract = "Background: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents{\textquoteright} dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. Objective: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. Design: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. Setting: A total of 37 UK residential and nursing care homes. Participants: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Interventions: Residents were randomised (1: 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Main outcome measures: Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. Result: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85\%) residents (transcutaneous posterior tibial nerve stimulation,n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78\% of the transcutaneous posterior tibial nerve stimulation group and 71\% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95\% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants{\textquoteright} scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. Conclusions: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context.",

keywords = "ABSORBENT PADS, COGNITION, COST–CONSEQUENCE ANALYSIS, ELECTRIC STIMULATION, FRAIL ELDERLY, NURSING HOMES, RANDOMISED CONTROLLED TRIAL, TIBIAL NERVE, URINARY INCONTINENCE",

author = "Joanne Booth and Lorna Aucott and Seonaidh Cotton and Bridget Davis and Linda Fenocchi and Claire Goodman and Suzanne Hagen and Danielle Harari and Maggie Lawrence and Andrew Lowndes and Lisa Macaulay and Graeme MacLennan and Helen Mason and Doreen McClurg and John Norrie and Christine Norton and Catriona O'Dolan and Dawn Skelton and Claire Surr and Shaun Treweek",

note = "Funding Information: Declared competing interests of authors: Lorna Aucott is a member of the National Institute for Health Research (NIHR) Public Health Research (PHR) panel and is a NIHR COVID Recovery and Learning Call Funding Committee member. Joanne Booth reports grants from the NIHR Health Technology Assessment (HTA) programme during the conduct of the study (16/111/31 – ICONS II: Identifying Continence OptioNs after Stroke randomised controlled trial). Claire Goodman reports work as a senior investigator for NIHR outside the submitted work, and membership of the Health Services and Delivery Research (HSDR) Commissioned – Board (2009–15). Doreen McClurg was a member of the HTA End of Life Care and Add-on Studies Group (2015–16). John Norrie reports grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study, and declares membership of the following NIHR boards: chairperson of the Medical Research Council (MRC)/NIHR Efficacy and Mechanisms Evaluation (EME) Funding Board (2019–present), the Cardiopulmonary Resuscitation Decision-making Committee (2016), the Health Technology Assessment (HTA) Commissioning Board (2010–16), the HTA Commissioning Sub-Board (Expression of Interest) (2016–19), the HTA Funding Boards Policy Group (2016–19), the HTA General Board (2016–19), HTA Post-Board funding teleconference (2016–19), NIHR Clinical Trials Unit Standing Advisory Committee (2018–present), the NIHR HTA and EME Editorial Board (2014–19) and the Pre-exposure Prophylaxis Impact Review Panel (2017–present). Funding Information: This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. Funding Information: The research reported in this issue of the journal was funded by the HTA programme as project number 15/130/73. The contractual start date was in July 2017. The draft report began editorial review in July 2020 and was accepted for publication in January 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors{\textquoteright} report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. Publisher Copyright: {\textcopyright} 2021 Booth et al. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = jun,

day = "1",

doi = "10.3310/hta25410",

language = "English",

volume = "25",

pages = "1--109",

journal = "Health technology assessment (Winchester, England)",

issn = "1366-5278",

publisher = "NIHR Health Technology Assessment Programme",

number = "41",

}

Booth, J, Aucott, L, Cotton, S, Davis, B, Fenocchi, L, Goodman, C, Hagen, S, Harari, D, Lawrence, M, Lowndes, A, Macaulay, L, MacLennan, G, Mason, H, McClurg, D, Norrie, J, Norton, C, O'Dolan, C, Skelton, D, Surr, C & Treweek, S 2021, 'Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT', Health technology assessment (Winchester, England), vol. 25, no. 41, pp. 1-109. https://doi.org/10.3310/hta25410

TY - JOUR

T1 - Tibial nerve stimulation compared with sham to reduce incontinence in care home residents

T2 - ELECTRIC RCT

AU - Booth, Joanne

AU - Aucott, Lorna

AU - Cotton, Seonaidh

AU - Davis, Bridget

AU - Fenocchi, Linda

AU - Goodman, Claire

AU - Hagen, Suzanne

AU - Harari, Danielle

AU - Lawrence, Maggie

AU - Lowndes, Andrew

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, Claire

AU - Treweek, Shaun

N1 - Funding Information: Declared competing interests of authors: Lorna Aucott is a member of the National Institute for Health Research (NIHR) Public Health Research (PHR) panel and is a NIHR COVID Recovery and Learning Call Funding Committee member. Joanne Booth reports grants from the NIHR Health Technology Assessment (HTA) programme during the conduct of the study (16/111/31 – ICONS II: Identifying Continence OptioNs after Stroke randomised controlled trial). Claire Goodman reports work as a senior investigator for NIHR outside the submitted work, and membership of the Health Services and Delivery Research (HSDR) Commissioned – Board (2009–15). Doreen McClurg was a member of the HTA End of Life Care and Add-on Studies Group (2015–16). John Norrie reports grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study, and declares membership of the following NIHR boards: chairperson of the Medical Research Council (MRC)/NIHR Efficacy and Mechanisms Evaluation (EME) Funding Board (2019–present), the Cardiopulmonary Resuscitation Decision-making Committee (2016), the Health Technology Assessment (HTA) Commissioning Board (2010–16), the HTA Commissioning Sub-Board (Expression of Interest) (2016–19), the HTA Funding Boards Policy Group (2016–19), the HTA General Board (2016–19), HTA Post-Board funding teleconference (2016–19), NIHR Clinical Trials Unit Standing Advisory Committee (2018–present), the NIHR HTA and EME Editorial Board (2014–19) and the Pre-exposure Prophylaxis Impact Review Panel (2017–present). Funding Information: This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. Funding Information: The research reported in this issue of the journal was funded by the HTA programme as project number 15/130/73. The contractual start date was in July 2017. The draft report began editorial review in July 2020 and was accepted for publication in January 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. Publisher Copyright: © 2021 Booth et al. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/6/1

Y1 - 2021/6/1

N2 - Background: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. Objective: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. Design: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. Setting: A total of 37 UK residential and nursing care homes. Participants: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Interventions: Residents were randomised (1: 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Main outcome measures: Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. Result: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation,n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. Conclusions: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context.

AB - Background: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. Objective: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. Design: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. Setting: A total of 37 UK residential and nursing care homes. Participants: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Interventions: Residents were randomised (1: 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Main outcome measures: Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. Result: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation,n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. Conclusions: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context.

KW - ABSORBENT PADS

KW - COGNITION

KW - COST–CONSEQUENCE ANALYSIS

KW - ELECTRIC STIMULATION

KW - FRAIL ELDERLY

KW - NURSING HOMES

KW - RANDOMISED CONTROLLED TRIAL

KW - TIBIAL NERVE

KW - URINARY INCONTINENCE

UR - https://www.scopus.com/pages/publications/85109366159

U2 - 10.3310/hta25410

DO - 10.3310/hta25410

M3 - Article

C2 - 34167637

AN - SCOPUS:85109366159

SN - 1366-5278

VL - 25

SP - 1

EP - 109

JO - Health technology assessment (Winchester, England)

JF - Health technology assessment (Winchester, England)

IS - 41

ER -

Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT

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