Clinical trial NCT03248362: ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes
Official title: ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes: ELECTRIC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2017-08-14
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic, multicentre, placebo controlled randomised parallel group trial
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether a programme of transcutaneous posterior tibial nerve stimulation (TPTNS) is a clinically effective treatment for urinary incontinence (UI) in care home residents and what the associated costs and consequences are.

Detailed description: 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 better quality evidence is needed that it works before it can be recommended for use in everyday treatment.

In this research the investigators will test TPTNS compared to dummy treatment in 500 people living in care homes who have urinary incontinence and who wear absorbent pads. The amount of urine they leak into participants' pads will be measured 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 the investigators if the treatment works and if it decreases leakage and if so, for how long. The investigators will ask the older person whether they feel their bladder leakage has changed and about any impact on their quality of life. The opinions of close family members and care home staff will be sought regarding whether they think TPTNS has had any effect on the participant. The investigators are also interested to learn about experiences of TPTNS, from residents, family and friends and all the staff involved. Costs of providing this treatment compared to the costs of providing continence care and pads will be determined and. the best ways to give TPTNS treatment in a care home, long term, will be explored with the care home staff.

Eligibility criteria: Inclusion Criteria:

* Care home residents:

  * with self or staff reported UI of more than once/week
  * who use the toilet or toilet aid for bladder evacuation with or without assistance
  * who wear absorbent pads to contain UI.

Exclusion Criteria:

* Care home residents:

  * with an indwelling urinary catheter
  * residents with UTI
  * residents with PVRU volume more than 300ml
  * residents with a cardiac pacemaker
  * residents with treated epilepsy
  * residents with bilateral leg ulcers
  * residents with pelvic cancer
  * residents on the palliative care register

Primary outcomes:
measure: Volume of UI leaked
timeFrame: 6 weeks post randomisation.
Secondary outcomes:
measure: Pad use
timeFrame: 6, 12 and 18 weeks post randomisation
measure: PVRU volume
timeFrame: 6, 12 and 18 weeks post randomisation
measure: PBBC
timeFrame: 6, 12 and 18 weeks post randomisation
measure: FC-PBC
timeFrame: 6, 12 and 18 weeks post randomisation
measure: S-PBC
timeFrame: 6, 12 and 18 weeks post randomisation
measure: Resident DEMQOL
timeFrame: 6 and 18 weeks post randomisation
measure: Staff DEMQOL
timeFrame: 6 and 18 weeks post randomisation
measure: RUQ
timeFrame: 6 and 18 weeks post randomisation.
measure: Semi structured interviews with residents, carers and staff regarding the impact of experiences of the TPTNS intervention and any impact on quality of life
timeFrame: 6 and 12 weeks post randomisation
measure: Semi-structured interviews and focus groups with care home staff and managers regarding the potential for integrating TPTNS into routine care within care homes, long-term
timeFrame: 6-24 weeks post randomisation
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
Study officials:
affiliation: Glasgow Caledonian University
name: Joanne Booth, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.
citation: 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. Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT. Health Technol Assess. 2021 Jun;25(41):1-110. doi: 10.3310/hta25410.
citation: Booth J, Aucott L, Cotton S, 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 DA, Surr C, Treweek S. ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial. Trials. 2019 Dec 16;20(1):723. doi: 10.1186/s13063-019-3723-7.