It's a problem nobody wants to talk about, suffering in silence and embarrassment. Of the 25 million Americans living with incontinence, 80% are women.

But a pacemaker for the bladder may be the answer.

"I couldn't go 20 minutes without having to go to the bathroom," Melissa DerManouel said.

She suffered for 12 years with overactive bladder.

"If it starts to go, there's no stopping mechanism," DerManouel said.

For people like DerManouel, their brains and their bladders don't communicate correctly. So, she was the first person in the United States to receive the new Axonics Sacral Neuromodulator, a remote-controlled pacemaker for the bladder.

"Basically, we're reprograming the nerve to the bladder," Dr. Felicia Lane said.

The neurostimulator is surgically implanted in the lower back, near the third sacral nerve root. A small lead wire delivers electrical impulses to the nerves that regulate bladder control.

"Our bladder can store our urine or hold our urine longer, and we're not having these involuntary contractions of the bladder that are unwanted," Lane said.

In previous devices, patients would need a new surgery to replace the stimulator every four years when the batteries died. The new stimulator lasts 15 years and can be charged just by wearing this charger over the area the device was implanted.

"There's nothing better than to see a bathroom and walk by it and not have to go," DerManouel said.

Sacral neuromodulation is the only Food and Drug Administration-approved therapy that can treat both urinary and fecal symptoms with a single solution.

Risks include infection after surgery, pain over the stimulator site and, if the device moves, it may have to be removed.

Right now the stimulator is only being used for patients who have failed to respond to traditional incontinence treatments.

MEDICAL BREAKTHROUGHS

RESEARCH SUMMARY

TOPIC: PACEMAKER FOR THE BLADDER

REPORT: MB #4696

BACKGROUND: Urinary incontinence or the loss of bladder control is a common and often embarrassing problem. Severity ranges from leaking urine when coughing or sneezing, to having the urge to urinate so suddenly that you can't reach a toilet in time. It occurs more often in elderly people, but it isn't an inevitable consequence of aging. Many people experience occasional symptoms or minor leaks of urine, while others may lose small to moderate amounts more frequently. Types of incontinence include stress, urge, overflow, and function. Stress occurs by exerting pressure on the bladder, urge is a sudden intense urge that occurs often (including throughout the night). Overflow is a frequent or constant dribble due to a bladder that doesn't empty completely, and functional is a physical or mental impairment that keeps you from making it to the toilet on time. It may be uncomfortable to discuss with your doctor, but if it is frequent or affecting your quality of life it is important to seek medical advice. It can restrict your activities, increase your risk of falls as you rush to the toilet, and indicate more serious underlying conditions. (Source: https://www.mayoclinic.org/diseases-conditions/urinary-incontinence/symptoms-causes/syc-20352808)

TREATMENT: Treatment will depend on several factors including the patient's age, level of incontinence, and general health. Pelvic floor exercises also known as Kegel exercises help strengthen the muscles that help control urination. Bladder training can also be attempted, aiming to control the urge by delaying the event, double voiding or urinating waiting a couple minutes then urinating again, or a toilet timetable with set scheduled times throughout the day can help a patient gradually regain control over their bladder. Medications may also be prescribed that can calm overactive bladders or reinforce tissue in the urethra and vaginal areas as well as lessen some of the symptoms. Medical devices such as urethral inserts, radiofrequency therapy, Botox, or bulking agents can also be used. Finally, several different surgery procedures are an option if other therapies do not work. (Source: https://www.medicalnewstoday.com/articles/165408.php#treatment)

AXONICS SACRAL NEUROMODULATION (SNM): The SNM System is used to treat urinary retention and symptoms of an overactive bladder. It uses an implanted stimulator, similar to a heart pacemaker device, to deliver electrical pulses through a wire to electrodes located near the sacral nerve. The device is surgically placed below the skin in the upper buttock area and attached to a wire that passes between the hipbones of the pelvis and ends at the sacral nerve. The IPG sends electrical pulses through the wire to the nerve that travels from the spinal cord to the bladder, thus helping improve control of the bladder. The system is used for patients who have failed or could not tolerate other treatments, such as lifestyle changes, pelvic floor exercises, or medication. (Source: https://www.fda.gov/medical-devices/recently-approved-devices/axonics-sacral-neuromodulation-snm-system-urinary-control-p180046)