How Solace Works

Stress Urinary Incontinence

Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine activities such as laughing, coughing, or walking. These and other everyday activities put temporary pressure (stress) on the abdomen and bladder. For women with SUI, this pressure can cause urine to leak involuntarily. SUI affects women of all ages including young mothers, pre-menopausal women, and seniors and can result in significant emotional distress.

The underlying causes of stress urinary incontinence are not well understood. It is believed to be caused by weakened pelvic floor muscles, which surround the urethra and help keep it closed during moments of increased abdominal pressure (laughing, exercising, etc). In some cases, the tiny muscles of the urethra itself lose their ability to maintain adequate pressures during stress-related events. Decreases in estrogen levels in menopausal women may also compromise the urethra’s ability to properly close. Any or all of these factors can play a role in the presence of SUI.

Current Treatment Options

Patient satisfaction with current treatment options has been limited. As a result, most patients are managing their urinary leakage with absorbent products including pads or diapers. The existing treatment options include:

• Muscle Retraining. For some patients, stress incontinence can be minimized by regularly exercising the muscles of the pelvic floor. These exercises (commonly called Kegel exercises) aim to improve pelvic muscle tone to keep the urethra closed during periods of stress. Electrical stimulation and biofeedback are often used in conjunction with these exercises to further stimulate and monitor pelvic floor muscle activity. For those patients that respond to pelvic floor exercise, regular routine exercise is required to derive a noticeable and sustainable benefit.
• Surgery. A variety of surgical operations are available to treat SUI. Though these procedures range in complexity and invasiveness, most aim to reinforce the tissues supporting the bladder and urethra. The most common surgical operation for SUI is the sling procedure, in which a strip of tissue or synthetic material is implanted under the urethra to provide compression and improve closure. Although surgery for SUI can be effective for some patients, these procedures have limited durability, require general anesthesia and can result in lengthy recovery times.

Solace AttenueX Balloon

The Solace Balloon is an investigational non-surgical alternative to your involuntary urinary leakage. It is a small, lightweight device (about the size of a quarter) that floats within the urinary bladder. It acts as a “shock absorber” to reduce the temporary pressure changes in the bladder that cause urinary leakage. The balloon is designed to eliminate or reduce your involuntary urinary leakage.

Without Solace Balloon		With Solace balloon

Solace Procedure

The Solace Balloon procedure is performed in your physician’s office. No fasting, medication or preparation is required before the procedure. Your physician will place the Solace Balloon into your bladder using a soft, tube-like catheter. Following placement, you can resume your normal daily activities. The only thing you must do is return to your doctor’s office every three months – he or she will monitor your progress and insert a new Solace Balloon.

For investigational use only. Not available for sale in the U.S.