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Medtronic begins post-market study of overactive bladder therapy

Medtronic : 02 November, 2007  (New Product)
Medtronic has started the InSite Trial, a post-market study of the company’s commercially available InterStim Therapy for Urinary Control, a treatment for overactive bladder and urinary retention.
The US Food and Drug Administration (FDA) has approved this study, which will aim to enroll more than 450 patients; those who qualify will be randomised 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.

“For many patients, a diagnosis of overactive bladder or urinary retention often represents a significant impairment in their quality of life,” said Michael E Carley, MD, MS, director of Urogynecology at Baylor University Medical Center, Dallas and an InSite Trial investigator.

“InterStim Therapy has allowed us to provide hope for those patients who were previously told their incontinence was not treatable and had failed all other interventions. The results of this long-term study will equip us with further clinical evidence of the potential benefits of InterStimTherapy 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.”

The study is designed as a prospective, multicentre, randomised trial comparing InterStimTherapy 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.

“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,” said Richard E Kuntz, MD, president of the Neuromodulation business at Medtronic.

“We recognise 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.”

InterStim Therapy for Urinary Control uses sacral nerve stimulation to improve bladder function. Originally approved by the FDA in 1997, 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.

Overactive bladder affects 33 million people in the USA alone. Worldwide, more than 40,000 people have been treated with InterStim Therapy.

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