Transcutaneous sacral nerve stimulation (tSNS)for constipation

• Research type

  Research Study

• Full title

  A pilot study to investigate the efficacy of transcutaneous sacral nerve stimulation (tSNS) for chronic constipation

• IRAS ID

  146382

• Contact name

  Carolynne Vaizey

• Contact email

  cvaizey@nhs.net

• Sponsor organisation

  North West London NHS Trust

• Research summary

  Constipation is a common problem, with an estimated worldwide prevalence of around 14% in adults. It is extremely disabling and negatively impacts upon an individual’s quality of life (QoL).
  Sacral nerve stimulation (SNS) first reported for faecal incontinence in 1995 and then for constipation in 2000 involves stimulating nerves in the spine which control the bladder, rectum and pelvic floor muscles. A series of small to medium sized studies have reported its beneficial effects in constipation. However, SNS is costs around £11000 per patient. It requires two operations carrying with it a risk of infection, risk of adverse stimulation and loss of efficacy in the long-term. Furthermore current funding restrictions in the UK make SNS for constipation very difficult to acquire.
  Transcutaneous sacral stimulation (tSNS) involves stimulating the same nerves as SNS but via trans-dermal patches over the sacral skin. It is cost-effective, safe and can be self administered by patients at home. Its effects in constipation have not yet been tested however it has demonstrated some benefit in faecal incontinence in two small studies.
  This pilot study aims to investigate the benefit tSNS in chronic constipation. 20 patients treated at St Marks Hospital, who have failed previous conservative therapies and are awaiting further treatments, will be recruited and treated with tSNS for 4 weeks. This will be self-administered by the patients at home. Patients will complete baseline QoL questionnaires and bowel and laxative diaries. They will be followed up by telephone consultation after one month to see when their symptoms have returned to baseline. The primary outcome measure will be assessed via changes to questionnaire scores and bowel frequency after 4 weeks of tSNS. Results from this study will provide evidence of its benefit in constipation for a larger clinical study.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/0486

• Date of REC Opinion

  30 May 2014

• REC opinion

  Further Information Favourable Opinion