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 AND METHODS: This investigation was a single-center, 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.
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 AND METHODS: This investigation was a single-center, 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.
Authors: T H Rockwood; J M Church; J W Fleshman; R L Kane; C Mavrantonis; A G Thorson; S D Wexner; D Bliss; A C Lowry Journal: Dis Colon Rectum Date: 2000-01 Impact factor: 4.585
Authors: Takeshi Takahashi; Sandra Garcia-Osogobio; Miguel Angel Valdovinos; Wilbert Mass; Ramiro Jimenez; Luis Alfonso Jauregui; Juan Bobadilla; Carlos Belmonte; Peter S Edelstein; David S Utley Journal: Dis Colon Rectum Date: 2002-07 Impact factor: 4.585
Authors: Andreas M Kaiser; Guy R Orangio; Massarat Zutshi; Suraj Alva; Tracy L Hull; Peter W Marcello; David A Margolin; Janice F Rafferty; W Donald Buie; Steven D Wexner Journal: Surg Endosc Date: 2014-03-08 Impact factor: 4.584
Authors: Giuseppe Dodi; Johannes Jongen; Fernando de la Portilla; Manoj Raval; Donato F Altomare; Paul-Antoine Lehur Journal: Gastroenterol Res Pract Date: 2010-12-27 Impact factor: 2.260