A New Wrinkle for Botox Treatments

January 25, 2006

Prior to October, Julia Smith suffered daily from an embarrassing and inconvenient medical condition, urinary incontinence due to an overactive bladder. But her life changed after she entered a clinical trial at the University of Rochester Medical Center testing Botox as a treatment.

 “You’d just never know when you were going to get the urge, and then you would have to move fast,” said Smith, a 67-year-old grandmother who lives in Hilton, N.Y. “It’s very difficult and people don’t want to talk about it.”

Smith tried medications and other therapy, but nothing worked, she said, until she consented to receive Botox injections directly into her bladder muscle. “It took a week to begin working and then it just stopped,” Smith said of her incontinence. “I found out that you don’t have to grin and bear it.”

Michael K. Flynn, M.D., M.H.S., assistant professor of Obstetrics and Gynecology and Urology, is leading the Botox research. Based on a pilot study he conducted while previously on the faculty at Duke University, Flynn was funded by the National Institutes of Health to open a larger study in Rochester.

 “When Ms. Smith entered our study, she had exhausted nearly all of her options to control her overactive bladder. The dramatic change in the severity of her leakage after the injection was remarkable,” Flynn said of the effects he observed in Smith. “We are optimistic that this medication will be as effective and safe as our preliminary studies suggest.”

His group plans to enroll 38 women such as Smith, who must be at least 21 years old and have severe leakage due to an overactive bladder. (Botox cannot help other causes of incontinence, such as from coughing, laughing, sneezing, infections or trauma.) The clinical trial compares two doses of Botox (200 units or 300 units) to a placebo. Patients who initially receive a placebo will have an opportunity to reenter the study later and receive one of the two doses of Botox, Flynn said.

The Food and Drug Administration has not yet approved Botox for this use. Manufactured by Allergan, Inc., the drug is FDA approved for certain cosmetic uses and to treat some neurological conditions. In general, Botox works by preventing nerves from sending signals to other nerves and muscles, and therefore preventing the muscles from contracting. Women with severe incontinence have bladder muscles that contract uncontrollably.

The studies on neurologic conditions treated with Botox have shown that Botox only affects the nerves and muscles near the injection site. Those treatments usually last three to six months and Flynn’s group hopes to find out if the effect will last even longer in the bladder. As part of the study, patients consent to regular checkups for nine months after the injection. The primary risk is that Botox could completely paralyze the bladder, leading to urinary retention and necessitating the use of a catheter until the medication wears off. Such side effects are unlikely, Flynn said, and should be temporary if they do occur.

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