Faecal Incontinence
Conditions
Keywords
percutaneous tibial nerve stimulation, anal physiology, faecal incontinence, partial response, long-term efficacy
Brief summary
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
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.
Interventions
None listed
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in faecal incontinence assessed by Wexner Score | Baseline compared to 3, 6, 12 and 36 months after start of PTNS | Rate of patients with improvement in faecal incontinence assessed by Wexner score (Maximum punctuation: 20 being severe incontinence. Minimum punctuation: 0, no incontinence). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictors of good long-term improvement in Wexner score | At 3, 6 and 12 months after start of PTNS | Influence of previous obstetric or surgery history and duration of symptoms in the variation of Wexner score |
| Partial Responders | At 3, 6 and12 months after start of PTNS | Incidence of patients with a decrease in Wexner score between 25 and 50% compared to initial value, and their performance in the long term |
Countries
Spain
Outcome results
None listed