INNOVO shorts provide stimulation to eliminate incontinence

Richmond Times-Dispatch (VA)

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DEAR DR. ROACH: I have seen news reports of many positive results from people using INNOVO, the FDA-approved shorts that provide electrical pelvic muscle stimulation, to possibly eliminate incontinence entirely. I also have heard that insurance companies may help pay the cost of these shorts. Since this may help many of your readers, can you comment on this product, which I've heard described as a "life-changer" from many of its users? -- Anon.

ANSWER: The INNOVO device uses electricity to contract the pelvic muscles and strengthen them -- a similar mechanism to doing pelvic floor (Kegel) exercises, which some women have difficulty doing. (Although both men and women may develop stress incontinence, the device is only for use in stress incontinence with women.) I wish I were as enthusiastic as you are about it, since more non-medication therapies for incontinence are definitely needed, but there are several points I need to clarify.

First, the INNOVO device is not FDA-approved. INNOVO is a Class II medical device, for which the FDA doesn't require approval. Approval is given for devices deemed to be "higher risk," and consequently, the FDA requires an extensive safety evaluation before a Class III device can be approved for use. The INNOVO device is "FDA cleared" and does not require a prescription.

I reviewed the studies examining the effectiveness of the device. Although some studies showed no difference between the INNOVO device and a placebo device that did not provide electrical stimulation, the studies that did showed a moderate benefit. One study noted 37% of women assigned to the INNOVO device found at least 50% improvement in leakage episodes, compared to 12% of women using the placebo device.

I did not find any study that showed an improvement in eliminating incontinence entirely compared to a placebo device. The device has not been shown to be better than pelvic floor exercises, which remains a preferred treatment.

I have no experience with insurance paying for this device, but the manufacturer states: "Some private insurers may provide coverage for incontinence treatments like INNOVO."

DEAR DR. ROACH: I often hear people say that an inherited/genetic disease skips a generation. This is in reference to any disease, from dementia, to breast cancer, to substance abuse, to rheumatoid arthritis (RA). I ask this because my wife's mother had severe RA, yet my wife and her sister don't show any signs of RA. Now, our daughter, at 35, has been diagnosed with RA. Is there any proven research that suggests genetic diseases skip a generation? Or is that just an old wives' tale? -- K.H.

ANSWER: I have respect for the old wives, since there is often a great deal of wisdom passed down through the ages. In the case of RA, a person who has a parent with RA is more likely to get it themselves than a person who has a grandparent with RA. Still, it is more common for RA to skip a generation than it is to show up without any family history at all.

There are several reasons a disease may skip a generation. Autosomal recessive conditions often do so. Sex-linked conditions are often "hidden" in females, but show up in their male offspring. A concept called variable penetrance may also explain why diseases skip generations.

There are more than 100 areas within the DNA that impact a person's risk for developing RA, so the situation is very complex, much more so than the single genes most people learn in school.

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Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to [email protected] or send mail to 628 Virginia Dr., Orlando, FL 32803.