Medtronic initiates post-market study of urinary control product

The study is designed as a prospective, multicenter, randomized trial comparing InterStim therapy to standard medical management for patients with symptoms of overactive bladder, including urinary urge incontinence and urgency-frequency. The primary endpoint of the study will be assessed after six months to demonstrate the success rate of InterStim therapy versus standard medical therapy. The study will provide significant long term safety evidence by following patients receiving InterStim therapy out to five years.

The FDA has approved this study, which will aim to enroll more than 450 patients. Those who qualify will be randomized to receive either InterStim therapy or standard medical treatment, including oral medications as determined by their physician. Patients implanted with InterStim Therapy will be followed out to five years. The results of this trial are expected to provide further clinical evidence of InterStim therapy’s efficacy in treating patients suffering from overactive bladder versus standard medical therapy.

InterStim therapy for urinary control uses sacral nerve stimulation to improve bladder function.

Richard Kuntz, president of the Neuromodulation business at Medtronic, said: “This clinical trial is one important example of our commitment to ensuring that we have the highest level of clinical evidence to support InterStim therapy and its role in helping patients who are suffering from the troubling symptoms of overactive bladder. We recognize that by further validating the clinical evidence with InterStim therapy, we also improve the chances that more patients who will truly benefit from this therapy will have access to it.”