2008 - SECCA CLINICAL Temperature-controlled radio frequency energy delivery (Secca® procedure) for the treatment of fecal incontinence: results of a prospective study
B Lefebure, JJ Tuech, V Bridoux, S Gallas, AM Leroi, P Denis, F Michot
Int J Colorectal Dis (2008) 23:993–997
PURPOSE Fecal incontinence (FI) is a debilitating condition that can be socially and personally incapacitating. A broad range of treatment options, often stepwise, are available, depending on severity. This prospective study reports a large single-centered series of patients who have benefited of temperature-controlled radio frequency (Secca) energy delivered to the anal canal.
MATERIAL & METHODS This investigation was a singlecenter, nonrandomized, prospective, clinical study of a single patient group with each serving as the control. All patients had experienced FI for at least 3 months and had attempted, but were not satisfied, with the results of medical and/or surgical therapies. The study aims to evaluate changes in FI symptom scores and quality of life between the baseline and follow-up intervals.
RESULTS Between March 2005 and March 2006, 15 Secca procedures were performed. All 15 patients were alive and in contact with the investigational site at time of 12 months. There were no long term complications. The mean Wexner score improved from 14.07 (±4.5) at baseline to 12.33 (±4.6) at 1 year (p=0.02). The mean fecal incontinence quality of life of life score was only improved in the depression subscore. There were no changes in endoanal ultrasound and anorectal manometry.
CONCLUSION This prospective trial confirmed the safety of the Secca procedure. Although we demonstrated a significant improvement in the Wexner Score, these clinical results have to be mitigated because most patients remained in the moderate incontinences category as defined by the scoring system and did not improved their quality of life excepted in the depression subscore.