A Medical Device Daily

Medtronic (Minneapolis) reported the initiation of the InSite Trial, a post-market study of its InterStim therapy for urinary control, a treatment for overactive bladder and urinary retention. The study will aim to enroll more than 450 patients, randomized to receive either InterStim therapy or standard medical treatment, including oral medications as determined by their physician. Patients implanted with InterStim 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 vs. standard medical therapy, according to the company.

InterStim therapy for urinary control uses sacral nerve stimulation to improve bladder function. It is indicated for the treatment of non-obstructive urinary retention and symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients for whom more conservative treatments have failed or caused intolerable side-effects.

Michael Carley, MD, director of urogynecology at Baylor University Medical Center (Dallas), and an InSite Trial investigator, said that the results of this 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.”