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Headline
This trial found transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence in the care home context.
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.
Results:
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 –5 ml (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.
Limitations:
Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data.
Future work:
Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes.
Trial registration:
Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 41. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Chapter 2. Trial design and methods
- Study design
- Ethics approval and research governance
- Participants
- Recruitment procedure
- Baseline visit
- Randomisation, allocation and blinding
- Intervention
- Comparison
- Treatment delivery
- Training
- Adherence monitoring
- Data collection
- Internal pilot study
- Participant withdrawal
- Sample size
- Statistical analysis
- Breaches
- Public and patient involvement
- Trial oversight
- Chapter 3. Trial outcomes and results
- Chapter 4. Economic evaluation
- Chapter 5. Qualitative study
- Chapter 6. Discussion and conclusions
- Acknowledgements
- References
- Appendix 1. Summary of changes made to the protocol during the ELECTRIC trial
- Appendix 2. Recruitment by centre
- Appendix 3. Protocol breaches/post randomisation exclusions
- Appendix 4. The ELECTRIC trial serious adverse events and adverse events
- Appendix 5. Unit costs and sources
- Appendix 6. Data completeness for calculation of utility values
- Appendix 7. Resource use data
- Appendix 8. Resource use: total number of contacts in the 6 weeks preceding data collection with each NHS service by groups, using all available data
- Appendix 9. Topic areas explored with participant groups
- Appendix 10. The ELECTRIC trial qualitative themes using theoretical domains framework V3 (March 2020)
- Appendix 11. Section of the analytic framework demonstrating the application of the theoretical domains framework knowledge domain to the care home staff data set (using NVivo 11)
- List of abbreviations
- List of supplementary material
About the Series
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).
Article history
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.
Disclaimer
This report contains transcripts of interviews conducted in the course of the research and contains language that may offend some readers.
Last reviewed: July 2020; Accepted: January 2021.
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