None listed
Conditions
Brief summary
Sacral Neuromodulation or SNM is a well-established treatment for bowel leakage, also known as faecal incontinence. It uses a small device (a stimulator) that is implanted under the skin in the upper buttock area. It then transmits electrical pulses through a small wire that is positioned close to the sacral nerve to improve bowel control and function. Despite being very successful for the treatment of faecal incontinence, the exact mechanism by which it works remains unknown. It is possible that SNM influences the way that the brain and gut interact by ‘resetting’ its function back to normal, a bit like restarting a computer after it ‘crashes’. If this is true, long-term SNM may not be necessary to control symptoms. The aim of this study is to assess the impact of SNM on bowel symptoms and bowel control, particularly when SNM is switched off. The group studied will include patients with faecal incontinence who have successfully been stimulated for at least 6 months. A total of 20 patients will be recruited and randomised into two groups; each group will have two cycles of different exposure. Each cycle will last for 6 weeks and will involve either turning the stimulator Off or On. Patients and assessors will be unaware whether the stimulator is On or Off, so as to reduce the effect of bias. At each 6-week cycle, all patients recruited will attend the hospital to adjust their stimulator and to complete a questionnaire and undergo physiology tests to measure bowel control and function. At the end of the study the SNM will be switched back to the original setting. Study outcomes will involve assessment of bowel symptoms, severity of faecal incontinence, quality of life scores and anorectal physiological function. This study will provide important information in understanding and treating disorders of bowel function and bowel leakage.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age >18 years 2. Predominant symptom: faecal Incontinence 3. Have been implanted with a permanent sacral nerve stimulator for at least 6 months 4. Subjective improvement in symptoms of faecal incontinence compared to baseline (i.e prior to the implantation of the stimulation device)
Exclusion criteria
1. Non-English speaking 2. Cognitive impairment 3. Non-ambulatory 4. Pregnancy 5. Neurological disorders e.g. Spina Bifida or Multiple Sclerosis