Vanderbilt University Medical Center is joining Medtronic’s ELITE clinical study of patients receiving the InterStim Micro sacral neuromodulation device. “Very, very few patients are offered advanced therapies and what we are able to accomplish at Vanderbilt is offer patients who have failed behavioral and medical therapies an opportunity to regain their quality of life,” said Dr. Melissa Kaufman, MD, PhD, professor of Urology and chief of the Division of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center.
VUMC’s ELITE Study Participation
The ELITE clinical trial will enroll up to 40 medical centers, including VUMC, to study 200 patients for two years. The goal is to better understand how living with the InterStim Micro impacts both their bowel and bladder control issue and their everyday lives. “[The InterStim Micro] is an exceptionally powerful technology and the ELITE study is one of several clinical trials for these devices that we have been involved in through the years,” said Dr. Kaufman.
Dr. Kaufman’s team implants an average of 10 to 15 devices per month and has been performing surgeries since the device was approved in 1997. Sacral neuromodulation is an area of significant advancement in treating pelvic floor issues and offers immense relief to patients.
Incontinence: Widespread and Undertreated
Bowel and bladder incontinence affects almost one out of every six Americans, an estimated 37 million people. The causes are wide-ranging, including neurological disorders, enlarged prostate or prostate cancer, childbirth, hormone loss such as during menopause, an injury to the back or pelvic region, and a number of other health conditions.
In addition to the physical symptoms, Dr. Kaufman said 90% of patients who have urgency incontinence also report mental health issues. Fear of leakage and the attached stigma causes those affected to withdraw from everyday life and experience isolation, depression and feelings of hopelessness.
Dr. Kaufman noted having observed this in her patients: “Patients are reticent to discuss it with their providers and therefore are undertreated. I have patients who have lost the capacity to go about any of their normal daily activities and avoid any company because of their fear of leakage.”
InterStim Micro Upgrades, Surgery and Recovery
The InterStim Micro device is the latest iteration of Medtronic’s endeavor to improve the reduced quality of life so many people experience. It’s a new version of the original device that’s been in use since 1997 when it was first approved by the FDA.
Unlike the previous model, the InterStim Micro has a rechargeable battery and allows for full-body MRIs without needing to be removed. The device works by helping the bladder reprogram how it senses filling and storage of urine, in order to reduce instances of urgency incontinence, said Dr. Kaufman. It stimulates peripheral nerves that send messages to the bladder.
During outpatient surgery, two small incisions are made above the buttocks near the sacrum, and the device is implanted. Recovery is relatively minimal, with pain medication for several days after surgery and only light activity for several weeks.