ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes

Urinary Incontinence Clinical Trial

— ELECTRIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03248362
• Other study ID #: 15/130/73
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2019
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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 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

Locations

Country	Name	City	State
United Kingdom	Glasgow Caledonian University	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Glasgow Caledonian University	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of UI leaked	Volume of UI leaked over a 24 hour period	6 weeks post randomisation.
Secondary	Pad use	Number of pads used in 24 hours	6, 12 and 18 weeks post randomisation
Secondary	PVRU volume	Post-void residual volume of urine scanned in bladder	6, 12 and 18 weeks post randomisation
Secondary	PBBC	Patient Perception of Bladder Condition	6, 12 and 18 weeks post randomisation
Secondary	FC-PBC	Family Carer Perception of Bladder Condition	6, 12 and 18 weeks post randomisation
Secondary	S-PBC	Staff Perception of Bladder Condition	6, 12 and 18 weeks post randomisation
Secondary	Resident DEMQOL	Resident perception of quality of life	6 and 18 weeks post randomisation
Secondary	Staff DEMQOL	Staff perception of quality of life	6 and 18 weeks post randomisation
Secondary	RUQ	Economic evaluation via a resource use questionnaire	6 and 18 weeks post randomisation.
Secondary	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
Secondary	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