Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence.
OBJECTIVE
In this prospective study we investigated the feasibility, safety, and efficacy of radio-frequency energy delivery deep to the mucosa of the anal canal for the treatment of fecal incontinence.


METHODS
We studied ten patients with fecal incontinence of varying causes. All patients underwent anoscopy, anorectal manometry, endorectal ultrasound, and pudendal nerve terminal motor latency testing at baseline and six months. The Cleveland Clinic Florida scale for fecal incontinence (Wexner, 0-20), fecal incontinence-related quality of life score, and Short Form 36 were administered at baseline, 1, 2, 3, 6, and 12 months. Using conscious sedation and local anesthesia, we delivered temperature-controlled radio-frequency energy via an anoscopic device with multiple needle electrodes to create thermal lesions deep to the mucosa of the anal canal.


RESULTS
Ten females (age, 55.9 +/- 9.2 years; range, 44-74) were enrolled and treated. Median discomfort by visual analog scale (0-10) was 3.8 during and 0.9 two hours after the procedure. Bleeding occurred in four patients (14-21 days after procedure), spontaneous resolution (n = 3) and anoscopic suture ligation (n = 1). At 12 months, the median Wexner score improved from 13.5 to 5 (P < 0.001), with 80 percent of patients considered responders. All parameters in the fecal incontinence-related quality of life were improved (lifestyle (from 2.3 to 3.4), coping (from 1.4 to 2.7), depression (from 2.2 to 3.5), and embarrassment (from 1.3 to 2.8); P < 0.05 for all parameters). Protective pad use was eliminated in five of the seven baseline users. At six months, there was a significant reduction in both initial and maximum tolerable rectal distention volumes. Anoscopy was normal at six months.


CONCLUSIONS
Radio-frequency energy delivery to the anal canal for treatment of fecal incontinence is a new modality that, in this study group, safely improved Wexner and fecal incontinence-related quality of life scores, eliminated protective pad use in most patients, and improved patient quality of life.
Service of Colon and Rectal Surgery, Departments of Surgery, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico.
Takeshi
T
Takahashi
Sandra
S
Garcia-Osogobio
Miguel Angel
MA
Valdovinos
Wilbert
W
Mass
Ramiro
R
Jimenez
Luis Alfonso
LA
Jauregui
Juan
J
Bobadilla
Carlos
C
Belmonte
Peter S
PS
Edelstein
David S
DS
Utley
D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000528:radiation effects*; D005242:Fecal Incontinence / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000528:radiation effects; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011846:Radio Waves / Q000009:adverse effects; D000078702:Radiofrequency Therapy; D012449:Safety; D016896:Treatment Outcome