Urinary IncontinenceELECTRICNCT03248362
ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes
A study testing Transcutaneous posterior tibial nerve stimulation in people with Urinary Incontinence, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Transcutaneous posterior tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- residents with bilateral leg ulcers
- residents with pelvic cancer
- residents on the palliative care register
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Transcutaneous posterior tibial nerve stimulation, Sham stimulation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous posterior tibial nerve stimulationDevice
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 stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| TPTNS Intervention | Experimental | 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. Receives: Device: Transcutaneous posterior tibial nerve stimulation |
| Sham stimulation | Sham comparator | 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. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of UI leaked
Volume of UI leaked over a 24 hour period
Measured: 6 weeks post randomisation.
Secondary outcomes (10)
Pad use
Number of pads used in 24 hours
Measured: 6, 12 and 18 weeks post randomisation
PVRU volume
Post-void residual volume of urine scanned in bladder
Measured: 6, 12 and 18 weeks post randomisation
PBBC
Patient Perception of Bladder Condition
Measured: 6, 12 and 18 weeks post randomisation
FC-PBC
Family Carer Perception of Bladder Condition
Measured: 6, 12 and 18 weeks post randomisation
S-PBC
Staff Perception of Bladder Condition
Measured: 6, 12 and 18 weeks post randomisation
Resident DEMQOL
Resident perception of quality of life
Measured: 6 and 18 weeks post randomisation
Staff DEMQOL
Staff perception of quality of life
Measured: 6 and 18 weeks post randomisation
RUQ
Economic evaluation via a resource use questionnaire
Measured: 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.
Measured: 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
Measured: 6-24 weeks post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start29 Jan 2018
- Primary completion30 Dec 2019
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, multicentre, placebo controlled randomised parallel group trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Joanne Booth, Prof, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248362
- Sponsor's protocol ID
- 15/130/73
- Acronym
- ELECTRIC
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2017
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23206722Fenocchi L, Mason H, Macaulay L, O'Dolan C, Treweek S, Booth J. Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial. BMC Geriatr. 2023 Nov 22;23(1):766. doi: 10.1186/s12877-023-04459-z.
PubMed 37993786Booth 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.
PubMed 34167637Booth 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.
PubMed 31843002
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes: ELECTRIC
- ClinicalTrials.gov ID
- NCT03248362
- Acronym / sponsor ID
- ELECTRIC / 15/130/73
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic, multicentre, placebo controlled randomised parallel group trial
| Arm | Type | Receives |
|---|---|---|
| TPTNS Intervention | Experimental | Device: Transcutaneous posterior tibial nerve stimulationTranscutaneous 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. |
| Sham stimulation | Sham comparator | Device: Sham stimulationSham 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Care home residents:
Key exclusion criteria (9 listed)
- Care home residents:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous posterior tibial nerve stimulation12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation | Device | TPTNS Intervention |
| Sham stimulation12 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 | Device | Sham stimulation |
Primary outcome
Volume of UI leaked
Time frame: 6 weeks post randomisation.
Volume of UI leaked over a 24 hour period
10 secondary outcomes
Pad use
Time frame: 6, 12 and 18 weeks post randomisation
PVRU volume
Time frame: 6, 12 and 18 weeks post randomisation
PBBC
Time frame: 6, 12 and 18 weeks post randomisation
FC-PBC
Time frame: 6, 12 and 18 weeks post randomisation
S-PBC
Time frame: 6, 12 and 18 weeks post randomisation
Resident DEMQOL
Time frame: 6 and 18 weeks post randomisation
Staff DEMQOL
Time frame: 6 and 18 weeks post randomisation
RUQ
Time frame: 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
Time frame: 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
Time frame: 6-24 weeks post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 23206722Booth 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.
- Derived from this study: PubMed 37993786Fenocchi L, Mason H, Macaulay L, O'Dolan C, Treweek S, Booth J. Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial. BMC Geriatr. 2023 Nov 22;23(1):766. doi: 10.1186/s12877-023-04459-z.
- Derived from this study: PubMed 34167637Booth 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.
- Derived from this study: PubMed 31843002Booth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Booth, Prof principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous posterior tibial nerve stimulation in people with Urinary Incontinence, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of UI leaked (time frame: 6 weeks post randomisation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248362, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.