Medtronic touts 5-year results in InterStim OAB treatment trial
Monday, July 17, 2017
Source: Mass Device
Medtronic (NYSE:MDT) today released results from a 5-year study examining the use of its InterStim sacral neuromod system for treating overactive bladder, touting that 82% of patients had a greater than 50% improvement in symptoms and sustained quality of life improvements.
Results from the InSite study were published in the Journal of Urology, the Fridley, Minn.-based company said.
“Effective long-term bladder control is critical because OAB is a chronic condition that significantly impacts all aspects of a person’s quality of life, including confidence, activities and intimacy. Many struggle to find long-term relief and these results, which show the InterStim system offers sustained long-term efficacy, meaningful symptom reduction and quality of life improvements, offer new hope for those who suffer,” primary study investigator Dr. Steven Siegel of Minneapolis, Minn.’s Metro Urology Centers for Female Urology and Continence Care said in a press release.
In the InSite trial, researchers looked to evaluate the efficacy and safety of the InterStim system for patients with OAB symptoms who failed or could not tolerate more conservative treatment, including urinary urge incontinence and urgency-frequency, the company said.
Results from the trial indicated an 82% therapeutic success rate as defined by the completers analysis, and a 67% using the modified completers analysis. A total of 45% of patients with urinary urge incontinence had complete continence, and had an average reduction of 2 leaks per day. Urinary urgency-frequency patients reported a mean reduction of 5.4 voids per day, the company said.
Patients in the trial also reported sustained quality of life improvements as measured by the ICIQ-OABqol questionnaire at a rate 3 times greater than what is considered clinically significant, Medtronic said.
The most common device-related adverse events were undesirable change in stimulation, implant site pain and ineffectiveness. Only 1 serious device-related adverse event was reported in the study.
“The InterStim system has been an important treatment option for 20 years and is the only sacral neuromodulation treatment with 5-year clinical data demonstrating sustained, long-term efficacy for the treatment of both OAB and fecal incontinence. These data should give physicians and patients confidence that relief and restored quality of life are possible and we hope this will help encourage the many still suffering from bothersome OAB symptoms to seek help,” pelvic health & gastric therapies biz GM Linnea Burman said in a prepared statement.
Last week, Medtronic said it launched a new study examining the use of its Arctic Front Advancecryoballoon in pulmonary vein isolation procedures for patients with symptomatic paroxysmal atrial fibrillation prior to antiarrhythmic medication treatment.