With over 18 million women reported to be affected, stress urinary incontinence (SUI) is definitely a medical condition that requires much attention. A number of concerned sectors have been extending extra efforts in coming up with alternative methods in treating this very common pelvic disorder especially with the vaginal mesh surgery mired in controversy.
Described by researchers as very promising, the intravesical pressure-attenuation device is one such innovation. This novel balloon-like device is intended to reduce or eliminate episodes of SUI among patients.
After inserting the polyurethane balloon-like device into the urethra, this is then inflated with correct volume of air. Once inflated, the balloon may act as a cushion in the bladder when abdominal pressure is exerted through activities like laughing, sneezing, coughing, and other physical movements. Urine leakage may be reduced or entirely eliminated when the sudden changes in pressure in the bladder is absorbed.
Clinical Trial Results
A clinical trial involving 166 women with SUI was conducted by a group of medical researchers aimed at testing the device’s efficacy and safety. One group which comprised 112 women was named the pressure-attenuation device group while the rest of the subjects were formed into the control group. The devices were inserted by doctors at the start of the study and replaced after a period of 90 days.
Recorded and evaluated by the researchers were the outcomes for every month up to the sixth month. It was determined at the end of six months, based on the subjects’ three-day voiding diaries, that urine leakage dropped from 4.4 per day to 2.5 or a 43.2 percent reduction. Improvement may be regarded as substantial especially when compared to the 24.1 percent reduction experienced by the control group.
While the initial results may be impressive, product developers may still have to hurdle a few challenges before this device may be embraced by the patients and healthcare providers. A number of non-serious adverse effects were reported and the 41 percent drop-out rate among participants may be far from satisfactory.
Advantages of the Pressure-Attenuation Device
Medical experts have acknowledged that as a first-generation device, the emergence of problems may be understandable. Necessary improvements or modifications to address all the issues encountered may still be undertaken.
Researchers have expressed optimism on this device as a new method in addressing SUI, notwithstanding the challenges. This type of approach has been shown to be effective, generally safe, simple to apply, completely reversible, and minimally invasive.
Any new method of treating SUI that shows great promise should be good news to all the women affected with this disorder. Patients have become wary of surgical procedures, such as vaginal mesh surgeries, which have caused severe complications to thousands of women.
Women who experienced these complications have sustained serious injuries, compelling them to file vaginal mesh lawsuits against mesh manufacturers. Trials of these lawsuits against different mesh manufacturers have been scheduled for 2014 with Ethicon accounting for seven vaginal mesh lawsuits.