Introduction Percutaneous Tibial Nerve Stimulation (PTNS) is a relatively new ambulatory therapy for faecal incontinence. Case series data suggest beneficial outcomes in 50–80% patients however the effectiveness of PTNS vs. sham has not been trialled. We aimed to assess the short-term efficacy of PTNS compared to sham electrical stimulation in adults with faecal incontinence.
Method In this multicentre, parallel-group, double-blind, randomised controlled trial involving 17 UK specialist centres, patients aged 18 years or over with significant faecal incontinence, who had failed conservative treatments were randomly assigned (1:1) to receive either PTNS or sham electrical stimulation. Randomisation was stratified by sex and then by centre in females. Patients and outcome assessors were masked to allocation for the 14-week duration of the trial when the effect of the intervention on severity of FI and quality of life was assessed using bowel diaries and validated questionnaires. A clinical response to treatment (primary outcome) was defined as a ≥50% reduction in weekly FI episodes. Secondary outcomes included reduction in mean weekly FI episodes, summative symptom scores, disease-specific and generic quality of life measures. ISRCTN registration number: 88559475.
Results 227 patients were randomised (from 373 screened) to receive PTNS (n = 115) or sham stimulation (n = 112). 12 patients withdrew; 7 from the PTNS group and 5 from the sham group. Missing data were multiply imputed. 39 patients in the PTNS group (38%) had a 50% or greater reduction in weekly FI episodes compared to 32 in the sham group (31%) (OR 1.28, 95% CI 0.72–2.28, p = 0.396). There was a significantly greater decrease in mean total weekly FI episodes in the PTNS compared to sham group (difference in means –2.3, 95% CI (–4.2 to –0.3), p = 0.02). This reflected a significant reduction in mean weekly urge (–1.5, 95% CI (–2.7 to –0.2), p = 0.02) but not passive episodes (–0.64, 95% CI (–1.67 to 0.40), p = 0.23). No significant difference in St Mark’s Continence Score was observed between groups (difference in means –0.047, 95% CI (–1.033 to 0.939), p = 0.93). No differences in the disease-specific Faecal Incontinence Quality of Life and Gastrointestinal Quality of life tools or the generic SF-36 quality of life tool were observed between the groups. No serious adverse events related to treatment were reported.
Conclusion PTNS did not confer significant clinical benefit over sham electrical stimulation in the treatment of adults with faecal incontinence.
Funding This project was funded by the NIHR Health Technology Assessment programme.
Disclosure of interest None Declared.