A prospective pilot study of biofeedback training with “Contrain” in patients with major Low Anterior Resection Syndrome (LARS) and faecal incontinence symptoms after anterior resection for rectal cancer

Each participant allocated to treatment will be given a training programme with the Contrain® multifunction trainer (Procon GmbH, Hamburg, Germany). Patients will undergo two 20-minute sessions per day for nine months, with encouragement to do this morning and evening. The initial session is supervised by a physiotherapist, and subsequent sessions are performed at home, with remote support from the study’s physiotherapist as required. The participant will be asked to perform exercises while standing, with the probe inserted into their anus or with skin pads surrounding the anus depending on patient preference. They will select the routines and intensity of the electrical stimulation. The Contrain gives immediate on-screen feedback, which includes clearly documenting the strength of the contraction of the pelvic floor and anal sphincters. Feedback on contraction strength is given in microvolts, and participants are encouraged to contract at >80% of their capacity, which is determined by maximal contractions with the device. This will assist participants to correctly perform the exercises as they can see what their values are. In certain routines the timing of the electrical stimulation can be co-ordinated with the electromyography (EMG) readings to help increase the strength of the maximal achieved muscle contraction, as well as improve neurological feedback to the brain. This is known as "triple target therapy", combining biofeedback, stimulation, and pelvic floor exercises. The number of exercises per day, and the performance in each exercise, will be recorded by the Contrain device. In addition to this, an intermittent clinical review (once every three months, for 30 minutes a session) will be performed by the study’s physiotherapist. At this time the performance in terms of frequency of exercise sessions and improvement in the strength of contraction will be reviewed. The ability of the participant to coordinate contraction, as well as relax the pelvic floor on bearing down, will also be reviewed. During the intervention, participants will not receive pelvic floor physiotherapy.