Clinical response and sustainability of treatment with temperature-controlled radiofrequency energy (Secca) in patients with faecal incontinence: 3 years follow-up

Background Controlled delivery of radio frequent energy (Secca) has been suggested as treatment for faecal incontinence (FI). Objective The objective of the study is to evaluate clinical response and sustainability of Secca for FI. Design This is a prospective cohort study. Patients This study involved patients who had failed full conservative management for FI. Interventions This study was performed between 2005 and 2010. Main outcome measures FI was scored using the Vaizey score (VS). A clinically significant response to Secca was defined as ≥50 % reduction in incontinence score. Impact of FI on quality of life (QOL) was measured using the FIQL. Data was obtained at baseline, at 6 months and at 1 and 3 years. Anal endosonography and anal manometry were performed at 3 months and compared to baseline. Results Thirty-one patients received Secca. During follow-up, 5/31 (16 %), 3/31 (10 %) and 2/31 (6 %) of patients maintained a clinically significant response after the Secca procedure. Mean VS of all patients was 18 (SD 3), 14 (SD 4), 14 (SD 4) and 15 (SD 4), at baseline, 6 months and 1 and 3 years. No increases in anorectal pressures or improvements in rectal compliance were found. Coping improved between baseline and t = 6 months. No predictive factors for success were found. Limitations This is a non-randomised study design. Conclusion This prospective non-randomised trial showed disappointing outcomes of the Secca procedure for the treatment of FI. The far minority of patients reported a clinically significant response of seemingly temporary nature. Secca might be valuable in combination with other interventions for FI, but this should be tested in strictly controlled randomised trials.