ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes (ELECTRIC)

ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes: ELECTRIC

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Transcutaneous posterior tibial nerve stimulation; Device: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G4 0BA
    • Glasgow Caledonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPTNS Intervention; Transcutaneous posterior tibial nerve stimulation (TPTNS) delivered in 30 minute sessions twice weekly over a 6 week period. The tibial nerve, which lies immediately posterior to the medial malleolus will be stimulated electrically using a portable TENS machine and two surface electrodes. The cathode electrode will be positioned behind the medial malleolus and the anode 10cm cephalad to it. Standardised stimulation parameters will be applied at 10 Hz frequency, 200µs-1 pulse width in continuous mode and stimulation intensity (mA-1) will be adjusted on a session-by-session basis according to individual resident comfort levels.	Device: Transcutaneous posterior tibial nerve stimulation; 12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation
Sham Comparator: Sham stimulation; Sham stimulation comprises low intensity, sub-clinical stimulation of the lateral sub-malleolar area, positioned specifically on the lateral aspect to avoid the tibial nerve, which runs close to the skin surface behind the medial malleolus. The stimulation parameters are identical to the TPTNS stimulation other than the intensity of the current which will be set at 4mA, rather than adjusted individually as it is in the TPTNS intervention group. The current will be initially increased until the resident reports feeling some sensation following which the current will be reduced down to 4mA. All residents will be informed that they may not feel anything with this intervention and that this is quite normal.	Device: Sham stimulation; 12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of of the lateral sub-malleolar area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of UI leaked	Volume of UI leaked over a 24 hour period	6 weeks post randomisation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pad use	Number of pads used in 24 hours	6, 12 and 18 weeks post randomisation
PVRU volume	Post-void residual volume of urine scanned in bladder	6, 12 and 18 weeks post randomisation
PBBC	Patient Perception of Bladder Condition	6, 12 and 18 weeks post randomisation
FC-PBC	Family Carer Perception of Bladder Condition	6, 12 and 18 weeks post randomisation
S-PBC	Staff Perception of Bladder Condition	6, 12 and 18 weeks post randomisation
Resident DEMQOL	Resident perception of quality of life	6 and 18 weeks post randomisation
Staff DEMQOL	Staff perception of quality of life	6 and 18 weeks post randomisation
RUQ	Economic evaluation via a resource use questionnaire	6 and 18 weeks post randomisation.
Semi structured interviews with residents, carers and staff regarding the impact of experiences of the TPTNS intervention and any impact on quality of life	Exploration of the experiences of the TPTNS intervention from the perspectives of residents, family carers and care home staff.	6 and 12 weeks post randomisation
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	Exploration of the factors affecting intervention implementation in the care home context and optimisation for sustainability	6-24 weeks post randomisation

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Joanne Booth, Prof, Glasgow Caledonian University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: 15/130/73

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No