This article is more than 5 years old. Information may no longer be current.
Secca procedure for fecal incontinence beats sham, but clinical impacts ‘negligible’
Click Here to Manage Email Alerts
Temperature-controlled delivery of radiofrequency energy using the Secca procedure improved severe fecal incontinence better than a sham procedure in a randomized controlled trial.
While this result was statistically significant, most patients experienced “negligible” clinical improvements, leading investigators to conclude that the procedure should only be recommended once patient factors associated with successful treatment are identified.
“A minimally invasive potential treatment for fecal incontinence is the administration of radiofrequency energy into the anal canal using the Secca system [Mederi Therapeutics],” Arjan Visscher, MD, of the department of gastroenterology and hepatology at VU University Medical Center in Amsterdam, said in a video abstract. “It is performed using a small anal scope which can manually deploy small retractable needles into the internal anal sphincter and by doing so inducing local fibrosis and collagen deposition, potentially remodeling the anus. The supposed mechanism of action is that by remodeling the anal canal one’s ability to obtain and recognize stool is increased.”
He added that about 5,000 Secca procedures have been performed worldwide.
To evaluate the clinical response achieved with Secca, Visscher and colleagues randomly assigned 40 patients with severe fecal incontinence who failed conservative treatment with antidiarrheal drugs, dietary fiber or pelvic floor physiotherapy, to undergo Secca or a sham procedure at an outpatient clinic between 2008 and 2015.
At 6 months, the Secca procedure improved fecal incontinence measured by the Vaizey incontinence score significantly better than the sham procedure (P = .02).
However, these scores significantly improved in both the Secca and sham groups, Visscher noted. “Of the 20 patients undergoing Secca, 90% remained moderately to severely incontinent of feces,” he said in the video abstract, adding that “10% of patients actually had a more than 50% reduction of fecal incontinence score.”
Additionally, fecal incontinence quality of life scores did not improve in either group at 6 months, nor did anorectal function at 3 months based on anal manometry and anorectal endosonography.
Visscher and colleagues acknowledged that the study included patients with severe fecal incontinence, which limits the generalizability of the findings.
“Though it significantly decreased the Vaizey incontinence score, most patients still remained moderately to severely incontinent of feces,” he concluded in the video. “Therefore, we do not believe that the Secca procedure should be recommended until patient-related factors which are associated with success are known.” – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts