Botox as Incontinence Therapy

By Jamie Santa Cruz

A minimal Botox procedure can provide dramatic results for older adults who experience urinary incontinence.

For the large percentage of older Americans who struggle with urinary incontinence, a growing body of research suggests that Botox is a therapy worthy of serious consideration.1-5

Close to one-half (44%) of Americans over the age of 65 who live at home struggle with urinary incontinence, and the figures are substantially higher for older adults who are institutionalized: Fully 75% of long-term nursing home residents lack complete bladder control. Both genders are susceptible, though the condition disproportionately affects women.6

A study presented at the American Urological Association annual meeting in June 2015, however, found that Botox is a highly effective treatment, with approximately 80% of patients reporting being "improved" or "greatly improved" following treatment.5 According to Victor Nitti, MD, a professor of urology and obstetrics/gynecology at New York University Langone Medical Center and one of the researchers involved in the study, the success rate in the study is similar to that reported previously in other studies and in clinical practice.

"The improvement [seen with Botox] is often much more dramatic than the types of improvement seen with medication," Nitti says. "That's not to say that you can't have somebody who starts on an oral medication and has a phenomenal response," but the likelihood is lower, he says.

Botox treatments for urinary incontinence are delivered by injection directly into the bladder, usually by a urologist but sometimes by a urogynecologist (in the case of female patients). As a naturally occurring neurotoxin, Botox works by blocking the binding of acetylcholine to the neurotransmitters between nerves going to the bladder and the bladder muscle itself. The bladder then loses the ability to contract, helping to prevent the unwanted bladder contractions that are associated with incontinence.

Each injection remains effective for a period of approximately six months, after which the treatment must be repeated. Nitti's recent study, which was the first to examine efficacy and safety over the long term, found that the injections continue to be effective even over a period of years, and no new safety issues arise with repeated injections.

Botox received approval in January 2013 from the FDA as a treatment for overactive bladder. Since then, Nitti says, use of the treatment has become increasingly common. Some primary care physicians likely are not yet fully aware of its potential, and there are some geographic areas where patients may not have access to the injections. But for those who do want Botox, Nitti says, it is generally fairly easy to find a physician who will perform the procedure.

Limitations
Although the treatment is growing in popularity, Nitti stresses that Botox injections are appropriate only in select circumstances. They are not indicated as a first-line treatment for overactive bladder; behavioral interventions should be attempted first, followed by oral medications. FDA approval of Botox has been given only for patients who have already failed medication treatment or experienced significant side effects.

The main drawback of the injections, according to Vanessa Elliott, MD, a urologist in private practice in Harrisburg, Pennsylvania, who does at least a few Botox treatments per week for her patients, is that they sometimes work too well. For some patients, Botox relaxes the bladder to such a degree that the patient develops problems emptying urine. In about 10% to 20% of those who receive the injections, the problem can be severe enough to require catheterization. Elliott explains that some patients require catheterization for a few days while for others the need may last for a few weeks.

For patients who do require catheterization after treatment, physicians have the option of giving a smaller dose for the next treatment, though this is not a course of action Nitti generally recommends. "The approval from the FDA is for 100 units,  [and] for neurological disease, 200 units is the appropriate dose," he says, noting that in early phase trials lower doses were shown to be mostly ineffective. "You can in select circumstances escalate or reduce the dose, but if you do that, you're doing it off label."

Although the inconvenience of catheterization may deter some patients, others may not care, Elliott says. Some of her patients with urinary incontinence are already catheterizing, but they opt for Botox injections because they are experiencing leakage of urine between catheterizations. For these patients, catheterization is already the norm and therefore not a particular concern.

Botox Compared With Other Treatment Options
Compared with oral medications, Botox holds several attractions for patients, according to Elliott. The injections offer more convenience than oral medications in the sense that they eliminate the need for patients to take pills every day. The injections also lack the side effects of medications, which Elliott says are significant enough to prompt a large percentage of patients to discontinue taking the pills after a few months.

Besides oral medications, the other major alternative treatment is sacral nerve stimulation, which involves implanting under the skin a stimulator that delivers electrical stimulation to the sacral nerve. But while sacral nerve stimulation is comparable to Botox injections in terms of effectiveness, according to Elliott, it requires surgery for the initial implantation of the device. Botox injections, by contrast, can usually be given under local anesthesia in a physician's office.

The price of Botox fluctuates, but the current cost is in the vicinity of $575 for 100 units (enough for one treatment), according to Nitti. Reimbursement to physicians averages $250 to $300 depending on the state, he says, so the total cost to the health care system is approximately $800 to $900 per treatment, with repeat treatments necessary approximately every six months.

While not inexpensive, per se, these costs are not necessarily out of proportion to alternatives. A 2013 study presented at the annual meeting of the American Urogynecologic Society found that the total cost per month of oral medications was higher than for Botox injections over a nine-month period.7 Meanwhile, the costs of Botox injections are roughly similar to the costs for sacral nerve stimulation, according to Elliott.

The latter option doesn't require follow-up nearly as frequently as Botox treatments (patients can generally go between three and five years before needing a battery replacement for the stimulation device), but the initial surgery to implant the stimulator is far more expensive than a Botox injection. Thus the costs work out to be comparable over time. (Before FDA approval, patients generally had to pay out of pocket for Botox injections, but Medicare and most other insurance plans now cover the injections, so patients generally do not see the costs directly.)

Suitable for Older Adults
In terms of identifying patients who are good candidates for Botox injections, Nitti believes the treatment is ideal even for older patients. "Most patients I treat are over 65, many are over 75 or over 80," he says. That's not to say Botox is not a good treatment for younger patients, he adds, since younger patients also tolerate the injections well, but the prevalence of overactive bladder is much higher in older adults. Physicians simply need to confirm that patients are willing and able to self-catheterize in the event catheterization becomes necessary, he says, but as long as doctors have this discussion with patients in advance, Botox is a "fine treatment" even for patients of advanced age.

Elliott agrees, arguing that for patients over the age of 70 or 75, the injections are preferable to surgery. But she says patients often need some education before they're willing to consider Botox. "For whatever reason, when patients hear the term Botox, it's very scary for them," she says. "A lot of them come to me [after] they have seen the ads on television, and they say, 'I don't want any of that in me.'"

Physicians need to communicate to patients that the procedure is quick, that it is typically tolerated well, and that quality of life can improve dramatically when patients don't require the use of pads and when they don't need to get up so frequently in the middle of the night. "It's very life changing [and] we need to stress that," Elliott says. "It's a pretty minimal procedure for a really big effect."

Nitti agrees that more physicians should consider Botox for their patients, and even those physicians who do not provide the treatment themselves should be aware that the treatment is available. "For any patient who could be an appropriate candidate, it really does deserve a sit-down to go over the expected risks and benefits. It really can be a life-changer for a lot of people."

— Jamie Santa Cruz is a freelance writer based in Englewood, Colorado.

References
1. Visco AG, Brubaker L, Richter HE, et al. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

2. Chapple C, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249-256.

3. Sievert KD, Chapple C, Herschorn S, et al. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014;68(10):1246-1256.

4. Nitti VW, Dmochowski R, Herschorn S, et al. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013;189(6):2186-2193.

5. Barbor M. AUA: Long-term use of Botox may decrease urinary incontinence. PM360 website. http://www.pm360online.com/aua-long-term-use-of-botox-may-decrease-urinary-incontinence/. Updated June 29, 2015. Accessed August 12, 2015.

6. US Department of Health and Human Services. Prevalence of incontinence among older Americans: Vital and Health Statistics, Series 3, Number 36. Centers for Disease Control and Prevention website. http://www.cdc.gov/nchs/data/series/sr_03/sr03_036.pdf. June 2014.

7. Brunk D. Cost of Botox vs. anticholinergics for urge urinary incontinence. Clinical Neurology News Digital Network. http://www.clinicalneurologynews.com/news/news/single-article/cost-of-botox-vs-anticholinergics-for-urge-urinary-incontinence/e96fe2470d146dae4239177b1551fa1b.html. Updated November 7, 2013. Accessed August 14, 2015.