Faecal incontinence Signs and Symptoms Faecal incontinence
Conditions
Interventions
The procedure involves placing an electrode (thin wire) on to the pudendal nerve laparoscopically (key hole surgery) under general anaesthesia. The wire is then connected to a small temporary battery
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with moderate to severe faecal incontinence for more than 6 months and suffering = two incontinence episodes per week 2. Patients should have had a trial of conservative management plus either be suitable for trial of sacral nerve stimulation (SNS) or have had unsuccessful outcome with trial of SNS 3. Patients willing to participate in this study 4. Age =18 years 5. Able to provide written and informed consent 6. Suitable candidate for surgery 7. Able and willing to comply with terms of the protocol including filling in questionnaires
Exclusion criteria
Exclusion criteria: 1. Presence of anal sphincter augmentation device i.e. FENIX or ABS 2. Chronic gastro-intestinal motility disorder causing incontinence due to diarrhoea 3. Active anorectal sepsis or disease such as cancer 4. External rectal prolapse 5. Pregnancy 6. Suspected or known allergy to titanium 7. Multiply scarred abdomen precluding laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Short-term safety and efficacy (Cleveland Clinic Incontinence Score (CCIS)) 2. Impact on Quality of Life (QoL) Measured prior to the surgery and 2 weeks after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in the percentage of successes, as defined by the device in use and = 50% improvement in the Cleveland Clinic Incontinence Score (CCIS), between pre-operative and 2 weeks post intervention 2. The safety of pudendal nerve stimulation as judged by explant rates and operative and post-operative complications 3. The effect on disease-specific QoL (Faecal Incontinence Quality of life Score (FiQol)) and overall QoL (SF-12 score) | — |
Countries
United Kingdom
Outcome results
None listed