Home based application of non-invasive tibial nerve stimulation in the treatment of overactive bladder

NIHR Devices for Dignity is leading the development of a definitive trial of self-administered, non-invasive and low-cost electrical stimulation for the treatment of overactive bladder syndrome symptoms, a condition which greatly affects people’s quality of life.

Project Lead and Organisation

Professor Christopher Chapple and Dr Martin Slovak, Sheffield Teaching Hospitals NHS Foundation Trust.

When did project start?

January 2011

Clinical Requirement

Overactive Bladder (OAB) symptoms affects over 5.15 million people in the UK population over the age of 40 [1]. People affected by OAB need to constantly plan their ‘escape routes’ to toilets when they’re out in public, and worry that they might smell due to leaks. This greatly affects their self-esteem and quality of life. These symptoms may be effectively managed using general lifestyle changes or education.  In England, the overall costs for over 6 million dispensed OAB drugs typically reaches £128.4 million every year. Although medication may improve the symptoms, many patients experience side effects that prevent them from willingly taking their medication as directed.   For patients for whom lifestyle changes and medication are not effective, they could be offered invasive and relatively expensive options such as electrical nerve stimulation on the ankle (Peripheral Transcutaneous Nerve Stimulation, PTNS), which uses needles and costs around £500 per month for each patient.  NIHR Devices for Dignity have explored an alternative approach to this stimulation technique which can be administered by the patient at home, with no needles, and at very low cost.

The Solution

The alternative approach to PTNS uses a conventional Transcutaneous Electrical Nerve Stimulation (TENS) stimulator with surface electrodes, placed on the ankle at the same location as that for PTNS. The TENS should activate nerves related to bladder control in a very similar way as that for PTNS, and with repeated use may help to manage the OAB symptoms. We have performed a placebo-controlled pilot study to explore this [2].  Participants used the TENS stimulator every day.  In this small scale pilot people using the active treatment reported greater improvements to their symptoms than those using placebo treatment.

NIHR Devices of Dignity are applying for funding to undertake a definite trial of this non-invasive intervention in the primary care setting and hope to start recruiting patients in 2018.

Impact

It is expected that the improvement in bladder symptoms will reach the level of those for PTNS (54.5% of patients reported a moderate or marked improvement) [3]. One of our previous pilot trial participant said that the improvement was better than that they had achieved from various drug therapies over several years [2]. The future definitive trial will help to address the recent NICE recommendation to further investigate these techniques. In addition there is also growing body of research looking at the links between the use of anticholinergic drugs (heavily use pharmacotherapy for OAB treatment) and the risk of dementia. The findings of this trial thus could be very timely in that it may prove to offer a safe and effective option for people affected by urinary incontinence where the main OAB treatment of anticholinergic drugs cannot be tolerated or is not safe.

Partners

The project was part of Training Urology Scientist to Develop Treatments (TRUST) network funded by the European Commission’s Research and Innovation Framework programme (Marie Curie Actions Initial Training Network Grant Number 238541).

References

Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ: How widespread are thesymptoms of an overactive bladder and how are they managed? A population-basedprevalence study. BJU Int 2002, 87:760–766.

Slovak M, Hillary C, Osman N, Chapple C, Barker A: Home based therapeutic application of non-invasive posterior tibial nerve stimulation in the treatment of overactive bladder symptoms: a pilot clinical trial. Neurourol Urodyn 2015, 34:S229–S230.

Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, MacDiarmid SA: Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. J Urol 2010, 183:1438–1443.