Company initiates long-term study of nerve stimulation for OAB, retention

Medtronic, Inc. has initiated the InSite Trial, a post-market study of its sacral nerve stimulation therapy (InterStim) for the treatment of overactive bladder and urinary retention. The FDA has approved this efficacy study, which aims 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.

“The results of this long-term study will equip us with further clinical evidence of the potential benefits of InterStim therapy for a large patient population and to consider its role in a standard algorithm for the treatment of patients with overactive bladder or urinary retention,” said Michael E. Carley, MD, MS, of Baylor University Medical Center, Dallas, and an InSite Trial investigator.

The study is designed as a prospective, multicenter, randomized trial comparing sacral nerve stimulation with standard medical management in patients with symptoms of overactive bladder, including urinary urge incontinence and urgency-frequency. Its primary endpoint will be assessed after 6 months to demonstrate the success rate of InterStim therapy versus standard medical therapy. In addition, the study will provide significant long-term safety evidence by following patients receiving the implant for 5 years.