One shot of Botox injection in the bladder works as well as daily medication for reducing episodes of urinary incontinence, and is more effective in completely resolving symptoms, a new study out of Duke University suggests.
The study is the first head-to-head comparison of Botox and anti-cholinergic drugs. The findings were published in the October 4, 2012, issue of the New England Journal of Medicine and presented at the annual meeting of the American Urogynecologic Society.
Injections of onabotulinumtoxin-A are currently approved by the FDA for urinary incontinence resulting from spinal cord or other neurological injuries, but are often used “off-label" for overactive bladder (OAB).
Researchers enrolled nearly 250 women with moderate to severe bladder incontinence, averaging five bladder leakage episodes a day. The women were randomly assigned to receive Botox injections in the bladder muscle along with 6 months of placebo pill or 6 months of anticholinergic medications and a placebo bladder injection. All patients who were assigned to oral medication were started on a low dose of solifenacin (Vesicare) and could increase to a higher dose if symptoms were not adequately controlled at 2 months. At the 4-month mark, patients could change to trospium XR (Sanctura). All pills were stopped at 6 months. At the end of the active treatment phase, 70% of women reported adequate symptom control. Specifically, women in both groups reported an average of three fewer leakage episodes a day.
Within 1 month after discontinuation of the oral regimen, fewer women assigned to the pill therapy reported adequate symptom control compared to the injection group – 50% versus 62%, respectively. At 1 year, 25% of the anticholinergic group and 38% of the Botox group still had adequate control. Women in the injection group were also twice as likely as those taking daily pills to report complete resolution of the problem, the study showed.
Both treatments had side effects. The pills caused dry mouth more frequently, and Botox injections resulted in more catheterizations and urinary tract infections, the study showed.
“This study has the potential to change how patients with urinary incontinence are treated,” says study author Anthony G. Visco, M.D., chief of urogynecology and reconstructive pelvic surgery division at Duke University Medical Center in Durham, NC, in a news release. “Patients need more choices than they have had up to now — would they rather take a pill for an indefinite period of time, or come in to the doctor’s office and have an injection about once a year? Both have their benefits and their side effects, but having more choices for women would be a great improvement.”
[Source: Duke University]