Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence.

Study Overview
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Brief Summary
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Percutaneous tibial nerve stimulation (PTNS) is an ambulatory therapy validated for patients with Faecal Incontinence (FI) refractory to conservative treatment with proved short and mid-term efficacy. The investigators therefore aimed to evaluate the long-term efficacy of PTNS, considered 3 years of follow-up. The investigators also aimed to identify predictors of responses and suggest a new approach for partial responders.

Detailed Description
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Prospective single-centre cohort of patients with FI treated with PTNS was analysed. PTNS sessions were performed in three phases: weekly for three months in the first phase, biweekly for three months in the second phase, and monthly for six months in the third and final phase. Clinical control at the end of each phase and an additional follow-up was performed at 36 months. Wexner score, faecal urgency, bowel habits and quality of life for FI were assessed. Patients were categorized in three groups: optimal responders when there was an improvement in Wexner score > 50%; partial responders if the improvement in Wexner score was 25-50%; and non-responders, when the improvement of Wexner score was < 25%. Optimal responders and partial responders progressed into successive phases, whereas non-responders abandoned PTNS and other treatment options were offered.

Official Title
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Long-term Efficacy of Percutaneous Tibial Nerve Stimulation for Faecal Incontinence and New Approach for Partial Responders

Conditions
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Faecal Incontinence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of faecal incontinence for more than 6 months, refractory to conservative treatment. Exclusion Criteria: Anatomic injuries that require surgery. External anal sphincter lesion of > 180º. Unavailability to attend regularly outpatient clinic. Major psychologic or psychiatric comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in faecal incontinence assessed by Wexner Score | Rate of patients with improvement in faecal incontinence assessed by Wexner score (Maximum punctuation: 20 being severe incontinence. Minimum punctuation: 0, no incontinence). | Baseline compared to 3, 6, 12 and 36 months after start of PTNS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of good long-term improvement in Wexner score | Influence of previous obstetric or surgery history and duration of symptoms in the variation of Wexner score | At 3, 6 and 12 months after start of PTNS | 
| Partial Responders | Incidence of patients with a decrease in Wexner score between 25 and 50% compared to initial value, and their performance in the long term | At 3, 6 and12 months after start of PTNS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous tibial nerve stimulation, anal physiology, faecal incontinence, partial response, long-term efficacy