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Effect of Percutaneous Tibial Nerve Stimulation on Fecal Incontinence: Results from a Double-Blind, Randomized, Sham-Controlled Trial for OverActive Bladder
Jeffrey A Ranta1, Ken Peters2, Donna Carrico2
1Greenwich Urological Assoc. P.C., Greenwich, CT;2William Beaumont Medical Center, El Paso, TX
Introduction: The Objective of this study was to compare efficacy of percutaneous tibial nerve stimulation (PTNS) to validated-sham treatment in the subset of overactive bladder (OAB) subjects diagnosed with FI using a seven-level Global Response Assessment (GRA) questionnaire defining responders as those reporting FI symptoms a "moderately" or "markedly" improved.
Materials & Methods: The study was a multi-center trial with 220 OAB subjects of which 28 subjects (13%) experienced FI. Of these subjects, 15 were randomized to PTNS and 13 randomized to a validated sham intervention. Both groups received twelve weekly 30-minute intervention in which the PTNS group received stimulations delivered through a 34-guage needle electrode inserted near the posterior tibial nerve, and the sham therapy used a placebo needle and a TENS device using sensory and auditory Methods to mimic the PTNS treatment without active treatment. Voiding diaries and validated questionnaires were completed at baseline, and after 6 and 12 treatments.
Results: Baseline characteristics were similar across both groups. The GRA for FI symptoms found 30.8% were responders in the PTNS group compared to 18.2% in the sham group aqfter 6 interventions and 45.5% and 18.2 after 12 treatments.
Conclusions: Although PTNS is not FDA cleared for use with those affected by FI in the United States, it suggests this treatment is not due to a placebo effect, is safe and effective, and has great potential for patients with FI
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