Study Reports SUI Episodes Reduced With Pressure-Attenuation Device

March 3, 2014

With over 18 million women reported to be affected, stress urinary incontinence (SUI) is without question a medical condition that deserves much attention. Especially with the vaginal mesh surgery mired in controversy, several concerned sectors have been putting extra efforts in coming up with alternative methods in treating this very common pelvic floor disorder.


The intravesical pressure-attenuation device is one such innovation, which has been described by researchers as very promising. Episodes of SUI among patients may be reduced or eliminated with the use of these novel balloon-like devices.


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.


Results of Clinical Trial


A group of medical researchers carried out a study involving 166 women diagnosed with SUI in order to test the efficacy and safety of this device. 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. Placement of the devices was done by the doctors at the start of the study and replaced after 90 days.


Recorded and evaluated by the researchers were the outcomes for every month up to the sixth month. Based on the subjects’ three-day voiding diaries, it was determined at the end of six months that there was a reduction in urine leakage by 43.2 percent – from 4.4 episodes per day to only 2.5 episodes. Improvement may be regarded as substantial especially when compared to the 24.1 percent reduction experienced by the control group.


Product developers may still have to hurdle a few challenges, despite the impressive results, before this device may be embraced by healthcare providers and patients. As it is, there have been a number of non-serious adverse effects reported and the drop-out rate of 41 percent among participants may be far from satisfactory.


Advantages of Device


The emergence of problems may be understandable considering that this is a first-generation device, as acknowledged by medical experts. Much may still be done to make the necessary improvements or modifications to address all the issues that were encountered.


Notwithstanding these challenges, researchers have expressed optimism on this device as a new method in addressing SUI. It has been shown that this type of approach is effective, generally safe, simple to apply, completely reversible, and minimally invasive.


Any developments in the treatment of SUI, particularly those that show great promise, should be regarded as good news to all the women affected with this disorder. For the thousands of women, a surgical option, such as a vaginal mesh surgery, which has caused severe complications, is something to be wary of.


Serious injuries have been sustained by these women, prompting them to file vaginal mesh lawsuits against mesh manufacturers. Litigation of these claims has been proceeding quite well with seven vaginal mesh lawsuits against Ethicon scheduled to be heard this year.




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