NCT05016453

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Faecal Incontinence

Timeline

• Start date: 2010-01-08
• Primary completion: 2017-06-15
• Completion: 2021-04-24
• First posted: 2021-08-23
• Last updated: 2021-08-23

Locations

1 site across 1 country: Spain