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The O-Shot: Incontinence fix or empty promise?

The "evidence" is anecdotal, but that doesn't appear to stop women desperate to solve an embarrassing problem. And there are plenty of doctors eager to help them get a therapy that lacks FDA approval or insurance coverage.

Trisha Smick of Medford (left) has a follow up visit with Dr. Beverly Mikes
Trisha Smick of Medford (left) has a follow up visit with Dr. Beverly MikesRead moreELIZABETH ROBERTSON / Staff Photographer

Following the birth of her third child in 2011, Trisha Smick began to experience embarrassing bladder-control issues.

A personal trainer and national fitness competitor, Smick, 49, of Medford, found that a simple cough or sneeze, or lifting a weight in a certain way, spurred a small leak of urine.

She performed Kegel exercises to strengthen her pelvic floor, which can be weakened during childbirth. She consulted a urologist. But she couldn't solve the problem.

So this spring, she turned to Beverly Mikes, a Cherry Hill ob-gyn who offers a controversial treatment called the O-Shot to treat stress incontinence and urinary frequency.

Urinary incontinence is a common condition in women. Approximately 25 percent of young women, around half of middle-aged and postmenopausal women, and three-fourths of older women experience some involuntary urine loss, according to the American Congress of Obstetricians and Gynecologists. The group estimates that $19.5 billion a year is spent on treatments, which run the gamut from behavior modification to surgery.

Then there's the O-Shot, meant for the 15 percent of women who have stress incontinence — leakage associated with a strain such as sneezing or lifting.

The O-Shot is an injection of platelet-rich plasma spun from the patient's own blood. If that concept sounds familiar, little wonder: It was developed by the same man who brought us the "vampire face-lift" that went viral when professional celebrity Kim Kardashian started touting it. The "vampire breast lift" is alleged to work similarly. Neither is approved by the Food and Drug Administration.

The Louisiana doctor who developed all these ideas, Charles Runels, also came up with the O-Shot, an injection of platelet-rich plasma into the clitoris, for the purpose of enhancing sexual pleasure.

There's no peer-reviewed scientific evidence that any of this works. But people who used the O-Shot started claiming that it helped with incontinence.

The evidence is anecdotal, but that doesn't appear to stop women desperate to solve an embarrassing problem. And there are doctors such as Mikes eager to help them — she is one of numerous doctors in the Philadelphia area and across the nation Runels lists on his oshot.info website.

The ob-gyn left private practice after 15 years to join the Hughes Center for Aesthetic Surgery in Cherry Hill, in part to treat stress incontinence with platelet-rich plasma. After all, she notes, the therapy has been used "for 20 years for painful, joints, arthritis, sports injuries, and wound healing."

The plasma contains "our bodies' own growth factors that stimulate cells to help increase collagen, elastin, as well as more vasculature and nerves," Mikes said. Therefore, "by stimulating new tissues and regenerating tissue, it can help treat stress incontinence."

Frustration over her inability to help women with stress incontinence with conventional therapy partly drove her to change her career, she said.

"You can have major surgery, or you can kind of live with it. Stress incontinence is not typically very responsive to medication. It was very exciting for me to offer women treatment that they otherwise would not be able to get in a typical office."

As for the lack of peer-reviewed journal articles on the O-Shot, "but that's true with anything new," Mikes said. "If we never embarked on new things, we wouldn't have the treatment we have today."

During Smick's procedure, Mikes drew blood from her arm, then used a special centrifuge to separate red blood cells from plasma, resulting in 5 cc's of the yellow serum of platelet-rich plasma or, as Mikes calls it, "liquid gold." After topical numbing and injection with a local anesthetic, four cc's of this serum was injected into Smick's interior vaginal wall and 1 cc directly into the clitoris.

"I have to admit that the idea of getting injections in the vagina and clitoris was unnerving," says Smick. "But in the end. it was pressure, but not pain."

According to Mikes, it takes a while to notice improvement. "After three months, there is a 65 percent success rate, and after three months a second shot can be given if the person has not experienced success," she says, noting that those who receive a second treatment experience an 85 percent success rate. Her figures come from a data bank maintained by Runels.

Mikes has treated about 25 patients since January. A single treatment is about $1,500 and is not covered by insurance. Depending on the patient's responsiveness to the O-Shot, Runels recommends a "yearly injection for maintenance sake," Mikes said.

Without strong evidence for its efficacy, the American Congress of Obstetricians and Gynecologists does not include the treatment in its Practice Bulletin for Urinary Incontinence in Women. L. Elaine Waetjen, professor of obstetrics and gynecology at the University of California, Davis Medical Center, who has spent more than 15 years treating women for this problem, said that there is "no scientific evidence that the O-Shot works for incontinence and there is also no clear biological mechanism for why it should treat this condition."

She noted in an email that although it is advertised as "a treatment for many different genitourinary problems … there is no scientific evidence that it works for any of these conditions."

Though some people may be swayed by someone else's positive experience,  "they need to be cautious because individual testimony does not control for the placebo effect of treatment," she said.

Waetjen added that there are many treatments for urinary incontinence that do have good scientific evidence. "They range from behavioral modification (e.g. reducing fluid intake and losing weight, as obesity can be connected with incontinence) to physical therapy, medication and surgery. A urogynecologist can offer women these different treatment options," she wrote.

Although Smick acknowledges that it might be a "coincidence," a few weeks after the procedure she said that she did feel some extra sexual sensation, and more bladder control.

"Normally I cross my legs in preparation when I sneeze," Smick said, "but lately I haven't felt the need to do that."

By mid-June, she said that her bladder control was "about 50 percent improved." While Smick once experienced bladder leakage while bending  over to lift weights or sneezing, now it's limited to "extreme situations, such as when I have a bad coughing fit. It doesn't happen day to day anymore," she said.

"I think that there are a lot of women who experience this problem, but not many people feel comfortable talking about it," she added. "I'm just very open and if I could be a spokesperson for this I would, even if it puts me out there a little bit."

mice30@comcast.net