Peters, K.M., et al. (2010). Poster, Society for Urodynamics and Female Urology, St. Petersburg, FL.
INTRODUCTION AND OBJECTIVES: Patients with overactive bladder (OAB) frequently have concomitant fecal incontinence (FI). The objective of this study was to compare the efficacy of percutaneous tibial nerve stimulation (PTNS) to validated sham treatment in the subset of OAB subjects diagnosed with FI.
METHODS: This multi-center, double-blinded, IRB-approved trial enrolled 220 subjects with OAB of which 28 subjects (13%) were diagnosed with FI. Of these subjects, 15 were randomized to PTNS and 13 randomized to a validated sham intervention. Both subjects and study coordinators were blinded to the intervention. Voiding diaries and validated questionnaires were completed at baseline, and after 6 and 12 treatments. In the PTNS group, stimulation was delivered through a 34-gauge needle electrode inserted near the posterior tibial nerve using the Urgent PC device for 12 weekly 30-minute sessions. The validated sham therapy used a placebo needle and a TENS device. Sensory and auditory methods were used to mimic the PTNS treatment although no active treatment was delivered during the 12 weekly 30-minute sessions.
RESULTS: Baseline characteristics were similar across both groups. In the PTNS group, mean age was 68.0 years with an average OAB duration of 13.5 years. Similarly, the mean age in the sham group was 67.2 years with an average OAB duration of 12.2 years. Average body mass index was 27.7 and 29.4 respectively. The Global Response Assessment (GRA) for FI symptoms found 30.8% were responders (moderately or markedly improved) in the PTNS group compared 18.2% in the sham group after 6 treatments and 45.5% and 18.2% after 12 treatments. In this same cohort of 28 subjects, OAB symptom improvement as measured by GRA was 26.7% and 15.4% after 6 treatments and 53.5% and 15.4% after 12 treatments for PTNS and sham subjects respectively. No serious adverse effects were noted.
CONCLUSIONS: GRA outcomes suggest that PTNS provides symptom relief for patients diagnosed with FI after receiving 12 weekly 30-minute treatments. Further research in larger study populations is needed.
Source: Original Poster
