BOWMAN V. 12.0

• Research type

  Research Study

• Full title

  A randomised sham-controlled, proof of principle study of abdominal functional electrical stimulation (ABFES) for bowel management (BOWMAN) in spinal cord injury (SCI)

• IRAS ID

  265067

• Contact name

  Tamsyn Street

• Contact email

  Tamsyn.Street@nhs.net

• Sponsor organisation

  Salisbury NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT04307303

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Many people with a spinal cord injury (80%) use one or more bowel management strategies. Electrical stimulation may provide a helpful technique for bowel management. People taking part in previous small studies using electrical stimulation have found they spend less time having a bowel movement and have improved comfort. Some people have also found improvements in bowel continence. Electrical stimulation could provide a further treatment used alongside other bowel management treatments to improve their effectiveness.
  The primary aim of this project is to find out if electrically stimulating the muscles in the abdomen is helpful for bowel management. Secondary to our primary aim, we will include measures for sexual functioning and bladder function to explore previously found improvements from using electrical stimulation. Studies have also found improvements in respiratory function from using abdominal electrical stimulation. We would also like to conduct an optional sub-study to measure respiratory function which will include 24 people with respiratory function issues.

  For the main study we would like to include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, with a complete or incomplete lesion in a medically stable condition, one year or more after their injury. Half will receive abdominal electrical stimulation and the other half will receive low dose abdominal electrical stimulation. We will ask people to keep a bowel diary and complete questionnaires to see if there is any difference from using abdominal FES. We will complete this initial study to see whether we can reproduce the results of previous smaller studies. If we find similar results then we will do further work to understand how the treatment works, who is most likely to benefit and the best way of administering the treatment so that we can maximize the benefit for patients.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  21/SC/0029

• Date of REC Opinion

  1 Apr 2021

• REC opinion

  Further Information Favourable Opinion