In this study, physicians from the United States evaluated the safety and efficacy of radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence.
The team enrolled 50 patients from 5 centers in this study.
|Patients reported a median 70% resolution of symptoms.|
|Diseases of the Colon and Rectum|
All patients reported fecal incontinence at least once a week for 3 months. Medical and/or surgical management had failed to help their symptoms.
The team asked the patients to complete questionnaires at baseline and at 6 months. The questionnaires included the Cleveland Clinic Florida Fecal Incontinence score (0-20), fecal incontinence-related quality of life, Short Form-36, and a visual analog scale.
All patients underwent anorectal manometry, endoanal ultrasound, and pudendal nerve terminal motor latency testing.
They received radio-frequency energy an anoscopic device with multiple needle electrodes (Secca® system) to create thermal lesions deep to the mucosa of the anal canal.
The physicians treated 43 females and 7 males, with a mean age of 61.1 years.
Patients' mean duration of fecal incontinence was 14.9 years.
The team determined that the mean treatment time was 37 minutes.
They found that at 6 months, the mean Cleveland Clinic Florida Fecal Incontinence score improved from 14.5 to 11.1.
In addition, all parameters in the Fecal Incontinence Quality of Life scales were improved.
Patients, as assessed by a systematic referenced analog scale, reported a median 70% resolution of symptoms.
The team also found that the mean Short Form-36 social function improved from 64.3 to 76.
There were no changes in endoanal ultrasound or pudendal nerve terminal motor latency assessment, or in anal manometry.
Complications included mucosal ulceration and delayed bleeding.
Dr Jonathan E. Efron's team concluded, "This multicenter trial demonstrates that radio-frequency energy can be safely delivered to the lower rectum and anal canal".