Study Reports SUI Episodes Reduced With Pressure-Attenuation Device

Stress urinary incontinence (SUI) is without doubt a medical condition that deserves much attention considering that an estimated 18 million women suffer from this ailment. As the controversy of the vaginal mesh surgery persists, efforts in finding alternative methods of treating this very common pelvic floor disorder have been exerted by a number of concerned sectors.


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.


Made of polyurethane materials, this balloon is inserted into the urethra through a tube and which is then inflated with the proper 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 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. At the start of the study, devices were inserted by the doctors and replaced after 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.


Before this device may be embraced by the patients and healthcare providers, product developers may still have to hurdle a few challenges in spite of the impressive results. 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. In addressing the issues encountered, there is still much that can be done, such as making the necessary improvements and modifications.


Even with these challenges, optimism on this device as a new method in addressing SUI was expressed by the researchers. As a treatment approach to SUI, this method has been claimed to be effective, simply to apply, completely reversible, minimally invasive, and generally safe.


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.


Due to these mesh implants, serious injuries have been experienced by women, which have resulted to the filing of 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.



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