A neurostimulator surgically implanted above the buttocks to reprogram how the bladder senses the filling of urine is helping patients with debilitating bladder and bowel disorders that are often life-limiting.
It is estimated that over 37 million American men and women suffer from incontinence, which translates to almost one-in-six people. It can be brought on by a number of factors including hormone loss, a back injury or pelvic surgery in the area.
"Ninety percent of patients who have urgency incontinence (leakage), report isolation, depression and even hopelessness," said Melissa Kaufman, MD, PhD, FACS, Professor of Urology and Chief, Division of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center (VUMC).
"And the stigma around this is a very real entity. 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.
Kaufman said that VUMC is joining the ELITE clinical study of InterStimTM Micro - the newest model of an existing technology used to help treat patients suffering with bladder and bowel disorders. Up to 40 centers will be enrolled to study 200 patients over a two-year period.
The new model is upgraded with a rechargeable battery and full-body MRI compatibility. The technology was approved by the FDA in 1997, but older devices have to be removed before most MRI procedures.
"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," Kaufman said.
"We offer treatments such as the InterStim to provide a way for the bladder to reprogram how it senses filling and storage of urine to reduce the episodes of urgency incontinence for the patient. It 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."
Kaufman, Stuart Reynolds, MD, MPH, associate professor of Urology, and Roger Dmochowski, MD, MMHC, professor of Urology and VUMC associate surgeon-in-chief, have implanted neurostimulators in patients to treat this condition several hundred times over the last two decades, averaging 10-15 per month.
The surgery to have the device implanted is an outpatient procedure and the recovery is straightforward for most patients, Kaufman said.
There are two small incisions less than a few inches on the back where the device is installed near the sacrum, on the top of the buttocks, so it is not actually near the bladder. It leads out into the peripheral nerves that provide signaling to the bladder.
Many patients use pain medication for a few days after the surgery and are asked to avoid any strenuous activity for several weeks
"Neuromodulation represents one of the most promising developments in pelvic floor medicine in the last two decades," Dmochowski said. "This treatment modality continues to evolve and become much more patient focused. The benefit to patients suffering with these conditions is immense."