A sham stimulation treatment was similarly effective in achieving a ≥50% reduction in weekly incontinence episodes.
Sacral nerve stimulation has become an important part of fecal incontinence treatment. An alternative, simpler procedure is tibial nerve stimulation. The tibial nerve can be accessed for either percutaneous or transcutaneous stimulation as it passes behind the medial malleolus of the ankle.
In the current trial, investigators in the U.K. randomized 227 patients with fecal incontinence to undergo percutaneous tibial nerve stimulation (PTNS) or sham stimulation once weekly for 12 weeks. Results were as follows:
A similar percentage of patients in the PTNS and sham groups achieved a ≥50% reduction in the weekly number of incontinence episodes (38% and 31%, respectively).
St. Mark's Incontinence Scores, disease-specific fecal incontinence quality-of-life scale scores, and generic quality-of-life measures were similar between groups.
Compared with the sham group, the PTNS group experienced significant decreases in weekly incontinence episodes and weekly urge incontinence episodes.
More patients in the PTNS group versus the sham group reduced loperamide use (29% vs. 11%).
The PTNS group showed a borderline-significant improvement (P=0.05) in patient-reported outcomes and a near-significant improvement (P=0.07) in global impression of success.
The sham techniques were not fully effective in blinding patients to treatment status, as 54% who received PTNS thought they had received it versus 31% of the sham group.
Reviewing Author
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)
Citation(s):
Knowles CH et al. Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): A double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial. Lancet 2015 Aug 17; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(15)60314-2)
Comment
This is a difficult trial to perform and interpret. Although the overall effect of PTNS is not impressive, a different conclusion might have been reached with a different primary outcome, and optimal primary outcomes for fecal incontinence are not established. The continued use of loperamide in the study, which decreased in the PTNS group, and the higher percentage of patients in the PTNS group who correctly perceived they had received PTNS, are also problematic. This study is unlikely to finish off PTNS.