Percutaneous afferent neuromodulation for the refractory overactive bladder: Results of a multicenter study

Purpose: More than 20 million Americans have an overactive bladder, the pre dominant symptoms being frequency, urgency, urge incontinence and pelvic pa in. While the etiology is not completely understood, most investigators bel ieve the causes to be many and the pelvic floor to be intimately related. W hatever the etiology, traditional therapies, including dietary manipulation , bladder drill, medications and physical therapy, are often poorly tolerat ed and/or ineffective. We report a prospective, multicenter clinical trial that was undertaken to determine the safety and efficacy of percutaneous pe ripheral afferent nerve stimulation for treatment of refractive overactive bladder and/or pelvic floor dysfunction. Materials and Methods: A total of 53 patients with overactive bladders, in whom all traditional therapy failed, were enrolled in 1 of 5 sites within t he United States. Patients received weekly percutaneous electrical stimulat ions via a 34 gauge needle placed near the tibial nerve 3 finger breadths a bove the ankle. Urodynamic studies, detailed voiding diaries, quality of li fe surveys, and incontinence impact questionnaires were completed before, d uring and after the study. Results: Of the patients with a mean age of 57.4 years 89% (47 of 53) compl eted the la-week study. A total of 71% of patients were classified as treat ment successes by the investigators and were started on long-term treatment . On average patients noticed a 25% reduction in mean daytime and 21% reduc tion in mean nighttime voiding frequencies (p < 0.05). Urge incontinence wa s reduced by an average of 35% (p < 0.05). Statistically significant improv ements were noted in selective pain and quality of life indexes. No signifi cant adverse events related to treatment were noted in any patients. Conclusions: Percutaneous peripheral afferent nerve stimulation offers a sa fe, minimally invasive and effective treatment for managing refractive over active bladder and/or pelvic floor dysfunction.