Sacral neuromodulation (SNM) was approved by the FDA for the treatment of urge incontinence in 1997. Since then it has received approval for urgency/frequency and idiopathic non-obstructive urinary retention (1999), and fecal incontinence (2010). Despite increasing applications and expanding usage, selecting the perfect patient for Interstim is not always easy. New data regarding SNM’s place in the treatment algorithm of OAB is always welcome. A recent publication in Neurourology and Urodynamics, Results of a Prospective, Multicenter Study Evaluating Quality of Life, Safety, and Efficacy of Sacral Neuromodulation at Twelve Months in Subjects With Symptoms of Overactive Bladder, presents data supporting the use of SNM in patients who have failed at least one, but not several anticholinergic medications. The authors investigated whether SNM could provide quality and durable treatment benefit in a “less severe” study population. This is a welcome addition to previously studied populations with refractory OAB.
An earlier phase of this trial, published in January 2014, was a prospective randomized control trial which demonstrated significantly improved quality of life and improvement in lower urinary tract symptoms for subjects receiving Interstim versus standard medical therapy. The current manuscript presents 12 month data from what will be a 5-year trial looking at cumulative adverse events and quality of life measures. Of the 340 study participants, 220 subjects were implanted with the device and had complete bladder diaries at one year follow up. Success was defined as ≥50% improvement in OAB symptoms. Clinical success was achieved in 82% of subjects. Quality of Life significantly improved in all 4 key quality of life measures from baseline to 12 months: concern, coping, sleep and social. The most common adverse events were undesirable change in stimulation, implant site pain, and implant site infection. This cohort will continue to be evaluated for 5 years.
Pub Med Link to study: http://www.ncbi.nlm.nih.gov/pubmed/25546568
Article by Sophie Fletcher on behalf of the Publications and Communications Committee.