Title: ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: ELECTRIC
Funder: Chief Scientist Office, Scotland

Abstract: Design:A pragmatic, multicentre, placebo controlled randomised parallel group trial comparing transcutaneous posterior tibial nerve stimulation (TPTNS) with sham stimulation for effectiveness in reducing urinary incontinence (UI) in 500 care home (CH) residents. An internal pilot with 100-140 residents and nested process evaluation will investigate intervention fidelity and implementation support for sustainability. Setting: CH (nursing or residential) for older adults in England and Scotland. Target population: Men and women resident in CH, with urinary incontinence (UI) of weekly or more frequent occurrence, including those with cognitive impairment. Inclusion criteria: CH resident; self/staff reported UI at least once/week; use toilet/toilet aid for bladder emptying, with or without assistance; wears absorbent pads to contain UI. Exclusion criteria: indwelling urinary catheter; urinary tract infection (UTI); post-void residual urine (PVRU) more than 300ml; cardiac pacemaker; epilepsy; bilateral leg ulcers; pelvic cancer; on palliative care register. Health technologies being assessed: Programme of TPTNS comprising 30 minute sessions delivered twice weekly for 6 weeks. Standardised parameter stimulation of tibial nerve adjacent to medial malleolus with intensity adjusted to resident comfort. Sham comprises sub-clinical intensity stimulation of lateral sub-malleolar area, to avoid tibial nerve. TPTNS will be delivered by CH nurses and senior carers. Facilitation to support implementation and embedding of TPTNS by staff will be provided. Measurement of costs and outcomes: Outcome measures (OCM) will be applied at 0, 6, 12 and 18 weeks post-randomisation. Primary OCM: volume of UI leaked over 24 hours as determined by a 24 hour pad weight test (PWT) measured at 6 weeks post randomisation (1g weight is equivalent to 1 ml urine). Secondary OCMs: number of pads used in 24 hours; PVRU; resident, family carer and CH staff Perception of Bladder Condition (PBC). The resident and proxy DEMQOL will be used to assess quality of life at baseline, 6 and 18 weeks. Resident characteristics will be recorded at each time point using a range of measures assessing individual cognitive, physical and functional status. Sequelae associated with UI will also be recorded. A process evaluation will record fidelity outcomes. Economic evaluation will assess costs and outcomes of the TPTNS programme and present them in a cost consequence analysis. Sample size: 500 residents based on estimated reduction in UI of 200ml/24 hours (effect size ~0.35, adjusting for loss to follow up and any clustering at sites) Difference between current and planned care pathways: Implementing TPTNS or sham will not require alteration to current continence pathways, which will continue in line with CH policies for both trial arms. These focus on continence promotion using scheduled and prompted voiding, fluid and environmental management and incontinence products. Project timetables including recruitment rate: 0-6 months: trial office set up, recruit trial staff, develop protocols and systems for recruitment, randomisation, data management; develop training materials; gain REC and management approvals. 7-24 months: RCT with 500 residents randomised across 20 sites over 18 months, recruiting 25-35 residents per month. The first 4 sites form the internal pilot. 30 months: Data collection complete. 30-36 months: data analysis. Expertise in team: members include experienced complex intervention triallists, statisticians, experts in continence, geriatrics, dementia and qualitative methods, a health economist and public representatives. Trial support, data management and statistical expertise provided by the Centre for Healthcare Randomised Trials at University of Aberdeen.

Lay abstract: Urinary incontinence is a distressing and embarrassing condition that occurs in around 70% older people who live in nursing or residential care homes. It is common in those who have dementia as well as those with other medical conditions. Urinary incontinence has a major impact on an older person’s dignity and quality of life and is linked to other health problems and relationship difficulties. It also affects a person’s ability and willingness to socialise. There are not many options for treatment of urinary incontinence in older people, especially those with dementia. There are several drugs available but these can have unpleasant side-effects. Sometimes pelvic floor muscle exercises, or going to the toilet at regular intervals are tried but these can be difficult to do by those who find it hard to get around or have memory problems. They are also hard to maintain in the longer term and so older people who experience bladder leakage usually rely on the use of absorbent pads to hold the urine, rather than trying to treat the cause of the problem. Transcutaneous posterior tibial nerve stimulation (TPTNS) involves placing two sticky pads (surface electrodes) on a person’s ankle and connecting these to a small, pocket sized electrical stimulator. This sends an electric pulse to the nerve near the ankle which also controls the bladder. Each treatment lasts half an hour and a total of twelve are given over a six week period. The treatment is similar to a TENS machine which is sometimes used for treating pain. It is a gentle pulsing and its strength is altered to suit the person and what is comfortable for them. TPTNS helps people with bladder leakage because it reduces the feeling of sudden urgency and the need to rush to the toilet and so gives people more warning and more time to find a toilet before they leak. TPTNS also increases the volume of urine the bladder is able to hold, so people do not need to empty their bladder as often. TPTNS has been tested in ten small studies but only one involved older people living in care homes and it only included 30 people. So far the studies have all indicated that TPTNS is safe and acceptable and that it can help bladder problems. However we need better quality evidence that it works before we can recommend that it is used for everyday treatment. In this research we will test TPTNS compared to dummy treatment in 500 people living in care homes who have urinary incontinence and who wear absorbent pads. We will measure the amount of urine they leak into their pads over a 24 hour period after six weeks (at the end of the TPTNS treatment programme) and after three and five months. This will tell us if the treatment works and if it decreases their leakage and if so, for how long. We will ask the older person whether they feel their bladder leakage has changed and about any impact on their quality of life. We will also ask the opinions of their close family members and the care home staff about whether they think TPTNS has had any effect on the older person. We are interested to learn about experiences of TPTNS, from residents, family and friends and all the staff involved. We will identify the costs of providing this treatment compared to the costs of providing continence care and pads. We will also explore with the care home staff the best ways to give this TPTNS treatment in a care home and keep it going in the long term.

Research activity codes: 6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: RENAL AND UROGENITAL