Stimulation of pudendal nerve for management of adult faecal incontinence using key hole surgery

Completed

Conditions: Faecal incontinence
Signs and Symptoms

Registration Number: ISRCTN49693042

Lead Sponsor: niversity of Leeds (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 10

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Short-term safety and efficacy (Cleveland Clinic Incontinence Score (CCIS))<br>2. Impact on Quality of Life (QoL)<br>Measured prior to the surgery and 2 weeks after surgery.

Secondary Outcome Measures

Name	Time	Method
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<br>2. The safety of pudendal nerve stimulation as judged by explant rates and operative and post-operative complications<br>3. The effect on disease-specific QoL (Faecal Incontinence Quality of life Score (FiQol)) and overall QoL (SF-12 score)<br>