title: Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence.
abstract: OBJECTIVE
  This multicenter study evaluated the safety and efficacy of radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence.
  
  
  METHODS
  Fifty patients at five centers were enrolled. All reported fecal incontinence at least once per week for three months, and medical and/or surgical management failed to help their symptoms. At baseline and at six months, patients completed questionnaires (Cleveland Clinic Florida Fecal Incontinence score (0-20), fecal incontinence-related quality of life, Short Form-36, and visual analog scale) and underwent anorectal manometry, endoanal ultrasound, and pudendal nerve terminal motor latency testing. On an outpatient basis using local anesthesia, radio-frequency energy was delivered via an anoscopic device with multiple needle electrodes (Secca system) to create thermal lesions deep to the mucosa of the anal canal.
  
  
  RESULTS
  Forty-three females and seven males (aged 61.1 +/- 13.4 (mean +/- standard deviation); range, 30-80 years) were treated. Mean duration of fecal incontinence was 14.9 years. Treatment time was 37 +/- 9 minutes. At six months, the mean Cleveland Clinic Florida Fecal Incontinence score improved from 14.5 to 11.1 (P < 0.0001). All parameters in the Fecal Incontinence Quality of Life scales were improved (lifestyle (from 2.5-3.1; P < 0.0001); coping (from 1.9-2.4; P < 0.0001), depression (from 2.8-3.3; P = 0.0004); embarrassment (from 1.9-2.5; P < 0.0001)). Responders, as assessed by a systematic referenced analog scale, reported a median 70 percent resolution of symptoms. The mean Short Form-36 social function improved from 64.3 to 76 (P = 0.003). There were no changes in endoanal ultrasound or pudendal nerve terminal motor latency assessment, or in anal manometry. Complications included mucosal ulceration (one superficial, one with underlying muscle injury) and delayed bleeding (n = 1).
  
  
  CONCLUSIONS
  This multicenter trial demonstrates that radio-frequency energy can be safely delivered to the lower rectum and anal canal. The Secca procedure significantly improved the Cleveland Clinic Florida Fecal Incontinence score and the overall quality of life for most patients having undergone the procedure.
authors.affiliation: Department of Colon and Rectal Surgery, Cleveland Clinic Florida, 6101 Pineridge Road, Naples, FL 34119, USA.
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: Efron
authors.forename: Marvin L
authors.initials: ML
authors.lastname: Corman
authors.forename: James
authors.initials: J
authors.lastname: Fleshman
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Barnett
authors.forename: Deborah
authors.initials: D
authors.lastname: Nagle
authors.forename: Elisa
authors.initials: E
authors.lastname: Birnbaum
authors.forename: Eric G
authors.initials: EG
authors.lastname: Weiss
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Nogueras
authors.forename: Scott
authors.initials: S
authors.lastname: Sligh
authors.forename: John
authors.initials: J
authors.lastname: Rabine
authors.forename: Steven D
authors.initials: SD
authors.lastname: Wexner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal / Q000294:innervation / Q000502:physiology* / Q000601:surgery; D000772:Anesthesia, Local; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D005242:Fecal Incontinence / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D010045:Outpatients; D011788:Quality of Life; D012007:Rectum / Q000294:innervation / Q000502:physiology* / Q000601:surgery; D012720:Severity of Illness Index; D016896:Treatment Outcome