Constipation Digestive System Other functional intestinal disorders
Conditions
Interventions
1. Anorectal physiology: this will take 30 minutes
patients selected for the study will be required to have full anorectal physiology investigations. This will consist of anal manometry, rectal sensory thresholds, pudendal nerve stimulation, endoanal
subjects will have rectal sensory thresholds to balloon distension after two weeks, at the crossover period, and at the end of the trial at 4 weeks. This consists of a balloon on the end of a catheter
Sponsors
Queen Mary, University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 65 years, either sex 2. Incomplete and/or assisted evacuation 3. Idiopathic (no rectal surgery, no spinal and overt neurological history) 4. Failed maximal conventional therapy 5. Normal colonic transit and rectal diameter 6. No significant mechanical obstructive abnormality on proctography 7. Unable to evacuate greater than 60% contrast in 3 minutes 8. Rectal hyposensation (based 2/3 abnormal values of first constant sensation [FCS], defecatory desire [DDV] and maximum tolerable volume [MTV] to balloon distension)
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent 2. Severe concomitant medical conditions precluding randomisation to operative treatment 3. Neurological diseases such as diabetic neuropathy, multiple sclerosis and parkinson's disease 4. Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers 5. Congenital anorectal anomalies or absence of native rectum due to surgery 6. Present evidence of external full thickness rectal prolapse 7. Previous rectal surgery (rectopexy/resection) done less than 12 months ago (24 months for cancer) 8. Stoma in situ 9. Chronic bowel disease such as inflammatory bowel disease, chronic uncontrolled diarrhoea 10. Anatomical limitations that would prevent successful placement of electrodes 11. Pregnancy or intention to become pregnant 12. Previous experience of sacral nerve stimulation (SNS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Normalisation of rectal sensory thresholds to balloon distension (first constant sensation, defaecatory desire volume, maximum tolerable volume) 2. Improvement in Cleveland Clinic Constipation scores 3. Increase in percentage of complete bowel movements from the bowel diaries Measured at baseline then after two weeks and then after 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements in the following criteria during the stimulation period: 1. Quality of life using validated methods of assessing health related quality of life (SF36) and gastrointestinal related quality of life (GIQoL) 2. Data from bowel diaries Measured at baseline then after two weeks and then after 4 weeks. | — |
Countries
United Kingdom
Outcome results
None listed