Medtronic (NYSE:MDT) is touting positive results from a study of its InterStim sacral nerve stimulator for treating less-severe overactive bladder syndrome, saying the device produces "superior efficacy and quality of life" compared with medication alone.
The Fridley, Minn.-based medical device company’s InSite study found that 61% of patients treated with the device reported "significant improvement" in OAB symptoms, defined as ≥50% improvement in average leaks/day, ≥50% improvement in voids/day or a return to normal voiding frequency of less than 8 voids each day. That compares with 42% of patients who reported similar improvement after standard medical treatment.
The study, results from which were presented at the American Urogynecologic Society’s annual meeting in Chicago yesterday, also showed improvement for patients with urinary urge incontinence who received the InterStim therapy. Seventy-one percent of those patients reported improvement, versus only 47% of the standard medical treatment cohort. Complete urinary continence was reported in 40% of the InterStim arm of the trial, compared with just 21% of the control arm.
And a quality-of-life questionnaire revealed that InterStim patients "had significantly greater improvements in OAB quality of life at 6 months," including "levels of concern, coping ability, sleep habits, social functioning, total health-related quality of life and a measure of how much urinary symptoms interfere with everyday activities," according to a press release.
"Average improvement in the total health-related quality of life score at six months in SNM was more than 3 times greater than that in [standard medical treatment]," according to the release.
"The InSite study results are an important input into the growing body of evidence about the standard of care for overactive bladder management," Cindy Kent, Medtronic’s general manager for gastro/urology therapies, said in prepared remarks. "The data clearly demonstrate that InterStim therapy is effective in helping patients manage their symptoms and enjoy their lives."
The study also revealed lower rates of adverse events for the InterStim patients, with 23.7% experiencing device-related adverse events and 26.0% of the control arm experiencing medication-related adverse events. But the rate of serious adverse events were higher for the InterStim cohort, at 7.8%, compared with 5.3% for the control arm.