Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence.
- Conditions
- Faecal Incontinence
- Registration Number
- NCT05016453
- Lead Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- Diagnosis of faecal incontinence for more than 6 months, refractory to conservative treatment.
- Anatomic injuries that require surgery.
- External anal sphincter lesion of > 180º.
- Unavailability to attend regularly outpatient clinic.
- Major psychologic or psychiatric comorbidities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain