Medtronic plc (NYSE: MDT) today announced that the InterStim(TM) system, which provides sacral neuromodulation therapy, offers sustained long-term efficacy and quality of life improvements for overactive bladder (OAB) at five years.1 Results of the InSite study, which were published online in the Journal of Urology,1 found that 82 percent of patients had therapeutic success (defined as a greater than 50 percent improvement in symptoms) at five years and sustained quality of life improvements.
Steven Siegel, M.D., primary investigator and director, Metro Urology Centers for Female Urology and Continence Care, Minneapolis, Minn. “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,” said “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.”
The prospective InSite study evaluated the efficacy and safety of the InterStim system at five-years in patients with bothersome OAB symptoms, who had failed or could not tolerate more conservative treatments, including urinary urge incontinence (UI) and/or urgency-frequency (UF). The five-year results include:1
- The overall therapeutic success rate was 82 percent using the completers analysis (subjects with data at baseline and each follow-up) and 67 percent using the modified completers analysis (subjects who either had a baseline and follow-up evaluation or withdrew early due to device-related reasons and are considered failures)
- Forty-five percent of patients with UI had complete continence
- UI patients had an average reduction of 2 leaks per day (p<0.0001) and UF patients had a mean reduction of 5.4 voids per day (p<0.0001)
In addition, patients experienced sustained quality of life improvements measured using the ICIQ-OABqol questionnaire (p<0.0001) that were three times greater than what is considered clinically significant
The InSite study demonstrated that the InterStim system was a safe option for OAB sufferers. The most common device-related adverse events were undesirable change in stimulation, implant site pain and ineffectiveness.1 The study reported only one serious device-related adverse event associated with the InterStim system.1 Implanting an InterStim system has risks similar to any surgical procedure.
Linnea Burman, vice president and general manager of the Pelvic Health & Gastric Therapies business, part of the Restorative Therapies Group at Medtronic added, “The InterStim system has been an important treatment option for 20 years and is the only sacral neuromodulation treatment with five-year clinical data demonstrating sustained, long-term efficacy for the treatment of both OAB and fecal incontinence.” Burman concluded, “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.”