From prep to follow-up: Key considerations for administering onabotulinumtoxinA

OnabotulinumtoxinA (Botox) has been FDA-approved for the treatment of overactive bladder (OAB) since 2013, yet clinical approaches to its administration continue to vary widely. To address this, a panel of 6 experts convened to develop consensus-based best practices to guide clinicians managing this condition.¹

Their recommendations cover critical considerations across all phases of treatment—before, during, and after the procedure—with a strong emphasis on optimizing the patient experience throughout. Specifically, these considerations include patient counseling on onabotulinumtoxinA; best practices for pre-procedure urinalysis, prophylactic periprocedural antibiotics, and optimal dosing regimens; ensuring patient comfort during the procedure; and monitoring for symptoms after therapy administration.

Benjamin M. Brucker, MD

In the following interview, co-author and panel member Benjamin M. Brucker, MD, provides a detailed walkthrough of these guidelines and discusses their practical implications for clinicians. He specifically addresses the importance of ensuring patient comfort throughout the entire journey—from when they check in at the front desk all the way through follow-up. These considerations, taken together, help to ensure patient compliance with treatment, he notes.

Brucker is a urologist and urogynecologist at NYU Langone Health in New York, New York.

Urology Times®: What were the aims for this paper?

Brucker: The hope of the paper was to update and give clinicians some guidance on how many of us are thinking about onabotulinumtoxinA. OnabotulinumtoxinA is a very effective therapy that's been in our treatment armamentarium for overactive bladder for many years. What happens with therapies, though, is, as we gain more experience, there are aspects of patient care and the patient journey that change. We wanted to look at all the different aspects of that patient journey and try to give some best practices and some tips and tricks.

The paper looks at something as simple as identifying the right patient and introducing patients to the therapy. When we discuss and introduce the therapy, it’s important that we talk about it in the right way. After we suggest [this therapy] and the [patient] wants to move forward with it, are there things that we should be doing from a practice efficiency standpoint to make the practice more efficient? Are there things that we should be doing from a patient comfort and patient experience standpoint? Are there any other tips and tricks to help continue the patient on the therapy? As we know, this is a therapy that will need to be continued if it's effective for the treatment of overactive bladder.

Urology Times: What are some of the misconceptions that health care professionals might have about this therapy that the paper aims to address?

Brucker: [One] preconceived notion is that we should save this for the challenging patient, or it should only be used in extreme cases. Patients with overactive bladder don't need to be the most severe patients to have this therapy introduced. With experience, you realize that there are so many patients out there who just may not want to deal with the cost of medication, may not want to deal with the side effects of medications, or may not [want to] settle for a therapy that might be inferior to the efficacy of onabotulinumtoxinA.

[Another thing is that] patients don't need to have tried multiple medications. In fact, even back when the product was originally approved, it was for patients who were intolerant of or not adequately treated by 1 or more, in that case, anticholinergic medications. It's important that when you look at the treatment options, you realize that this is an option from the beginning.

[However,] there are patients who come in and have already tried numerous therapies. Many have tried therapies or at-home remedies from other providers, [or] they've maybe gotten prescriptions in the past. It's a little off-putting if they come to see as an expert, as a urologist or uro-gynecologist, and we say, "Go do your Kegel exercises and cut back on the coffee and soda," and those are things they’ve done already. We want to introduce [onabotulinumtoxinA]. We want to make them aware that it's available therapy for them, and it does sometimes take a couple of different touch points with the patient for them to understand how onabotulinumtoxinA will work and how effective the therapy can be.

Urology Times: What is the significance of confirming the diagnosis of OAB before outlining treatment options?

Brucker: As clinicians, there are a lot of conditions that end up having urinary symptoms. When we're in the realm of urgency and frequency, there are things that can mimic overactive bladder. But if we remember that the hallmark feature of overactive bladder is urgency, and we look at things like the AUA [American Urological Association/SUFU [Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction] guidelines on overactive bladder, we realize there's not a whole lot of diagnostic testing in most cases. If the history is consistent with overactive bladder, we've checked their urine analysis and there's no hematuria or infection that needs to be evaluated or treated, and we know that the patient's bladder is emptying, that's really all we need. It is important to identify the patient appropriately, but that identification should not be a barrier to considering or even introducing a therapy like onabotulinumtoxinA.

We do want to make sure that there are certain things we do; [for example], making sure patients are not consuming large quantities of fluid, making sure they're not terribly constipated or having bowel issues that might be contributing, [and they are] screened for other concomitant types of incontinence, like stress incontinence or issues related to overflow. But with a simple in-office discussion, we can start introducing the concept of this condition, overactive bladder, which, as many of you know, affects quite a few patients. [It is] thought [that] upwards of 1 in 6 patients has an overactive bladder. The patients are out there. It's not hard to identify them with some basic in-office questions and a simple evaluation.

Urology Times: What specific strategies do you recommend for introducing this therapy to patients during the initial visit, particularly when you're discussing the risks and the benefits?

Brucker: In terms of introducing onabotulinumtoxinA or any advanced therapy, we want patients to be aware that there is an option. Maybe [patients have] gotten a pill in the past, [but] they may not realize that there's something beyond the medication. [It’s] very effective [to use] a care pathway. There are plenty of practices that will have care pathways of their own. For example, SUFU puts together some aids to help patients and physicians understand [these options].

Forward thinking [is also important.] The AUA and SUFU, in their updated AUA guideline on overactive bladder, do mention step therapy, where you try a first-line [therapy,] and then a second-line, and then the third-line, which was the old way we thought about it. I do believe that you need to know what the options are, so that you can appropriately select. There are going to be [adverse events], efficacy differences, and different logistical cost considerations for therapies. But you could imagine if the first time that you're ever hearing about it is when the doctor is saying, “This is what you need,” you might not have the time to talk to friends, talk to family, or talk to your primary care [provider]. I think introducing [this treatment] early is very important.

The other thing that is unique to onabotulinumtoxinA is it's a pharmacotherapy, but it's not just a pill that you take. Even some of the basic logistics of how it's done, what’s expected, and retreatment are things that do also need to be addressed. It's important to keep the language simple. We don't want to overwhelm patients when we talk about medications. Then, after we've told them that it's effective and how it's going to be administered, we'll start talking about things like the potential [adverse events], and finally, if there are any cost considerations. OnabotulinumtoxinA is really no different in that we need to introduce the therapy in a basic way, which is, what is it intended to do, and how do we do it? We don't want to skirt away from the safety, but we don't necessarily need to lead with that. That's, I think, a very important way about the dialogue related to something like onabotulinumtoxinA.

Urology Times: What are some practical techniques that you use to help reduce some of the patient anxiety and discomfort that they might have either before or during the procedure?

Brucker: When you have any office-based procedure, there's going to be a little anxiety. First and foremost, making sure that my office knows what the procedure is is important. There are going to be multiple people in my office who have dialogue with and interact with patients before I come into the room to do the procedure. The procedure might only last about a minute/a minute and a half, [but there are other aspects of care]. The patient will need to check in at the front desk; we want to make sure that the people at the front desk understand what the visit type is. We want to make sure that the [medical assistants] that are putting them in the room appropriately explaining to them what the wait may be. A lot of [this is] just basic customer service. We want to make sure that patients are comfortable, because we realize this is going to be a recurring potential procedure for them.

There are things that can happen before a patient has the procedure that need to be thought about or addressed. If I put a patient up in stirrups and I leave them up in stirrups for 20 or 30 minutes, and then they end up getting cold and their legs are tired, it's not a pleasant experience. If we're going to use, let's say, an analgesic in the bladder, or something like a lidocaine, we're going to tell patients that they don't need to keep their legs up. I don't want the automatic light in the room to go off and the patient worries, "Did they forget about me in here? It's been quite a while."

We like to make sure that the medical assistant who's rooming the patient is aware and can start to develop a bit of a rapport. Are there certain fears that they have? Certainly, I'll ask if there are any questions a patient has, but they might be a little embarrassed or concerned about saying something. [However,] the [medical assistant] who’s sitting and talking with them might realize that they have a concern about something like a urinary tract infection. That's very easy for me to address upfront, so that there's a little less worry or anxiety.

In the actual procedure itself, I want to make sure that I don't have all the equipment laying out so the patient's looking at all these tubes and needles and syringes. Using a sterile drape, we can cover our set that we have for the actual injection itself. We want to make sure that when we're considering the room, [we do] things like dimming the lights [that] might make it a little less stressful or a little bit more comfortable. We've even used things like a lavender scent. The data are mixed on whether it works or doesn't work, but I don't think there's any harm in considering things like soft music or comforting music.

More and more, what we're doing is asking patients if there are other things that they like or don't like to make the situation more comfortable. When I get in my car, I have to adjust my seat to where I like it, I adjust my mirror to where I like it, I turn the radio to what I like, and then I feel more comfortable driving to work. For a patient, it's no different. They have certain things they like. They know that they like to have; let's say, a squeezy ball to squeeze in case they're having pain or discomfort. We can provide that to them.

Then, we talk a little bit about what the “during the procedure” will be, just so that if it's their first time, they're not wondering why I'm talking to the medical assistant or why I'm doing certain things. We talk a lot about where their eyes should be, whether they want to watch or not watch. We try to tell people not to close their eyes [and] not to scrunch their face, because that sometimes exacerbates or worsens some of the symptoms or concerns that they have. Then we want to make sure that after the procedure, it's pretty clear what the follow-up will be.

The whole journey that the patient's in the office could be 30 minutes, maybe an hour, but the actual procedure itself is much shorter. That's where we really need the team to be on board to make it a very positive patient experience.

Urology Times: Given the variability in expert opinion on pre-procedure urinalysis (UA), what factors do you consider when deciding whether to perform UA before administering this therapy?

Brucker: I think if you ask 100 experts, you'll probably get 100 different answers. When doing a clinical trial on onabotulinumtoxinA, you can understand why a urine analysis, even a urine culture, was needed. We don't treat patients with asymptomatic bacteriuria. What we’ve realized is if the bladder is not inflamed or giving signs of, for example, dysuria, we may not necessarily need to look. Those who use urine analysis may argue that they want to know if there's an active infection. On the other side, if there's an active infection, a patient will have symptoms, notably dysuria, which is probably the most sensitive and specific of those symptoms.

There may be other things that we're looking at in a urine analysis that give us data. So, other clinicians may want to know what other cells are there? Are there any other concerning findings? Urine analysis is often done as part of the initial evaluation, and maybe these patients have been seen before in the practice. So, it may not be the first time they've had it. Certainly, in someone who's had symptomatic infections or is at a high risk for a symptomatic infection, in patients who are immunocompromised, or [in patients whom] have other medical conditions, we may want to be more vigilant. We’ve gotten a little bit more lax, because there are data out there that say whether you check a urine analysis or urine culture, it may not ultimately affect whether you get an infection or not. So, if a patient comes in and has a positive urine analysis, but we look in the bladder and everything's fine, they don't have symptoms, and it's an asymptomatic issue, are we just going to cancel the patient and then necessitate antibiotics with the potential [adverse events] of that? For those reasons, I would say come up with what works for your practice. There are patients who may be high risk, so maybe you're pre-treating with antibiotics. Then there are others who are going to be just the day-of, and then some patients probably don't need a UA or urine culture.

Urology Times: How should clinicians think about dosing for onabotulinumtoxinA?

Brucker: One of the other things that has changed in my practice, and I think the white paper alludes to, is the number of injections. When onabotulinumtoxinA was first brought through the approval process, in a somewhat arbitrary manner, the decision was made to do 20 injections. Twenty injections means 20 potential interactions with the bladder mucosa or urothelium that can cause bleeding [and] 20 interactions that could cause pain for the patient.

What we've realized from some of the studies that have been done and our practical experience is that using fewer injections may not have any negative impact on efficacy, but may make the procedure more efficient, which is good, and also a bit more comfortable. I have landed on about 10 injections at this point because I think it's a good balance of spreading the onabotulinumtoxinA around, and if 1 of the injections is too deep or too shallow, [I don't want to] waste too much of the product. It's more uncommon now that for an idiopathic patient I'll go forward with the 20 injections, a half cc each. I'll just use a little bit of a larger volume. Some of my colleagues will use 5 or even 1 injection. When using fewer injections, it’s important that the medical assistant, if they’re pushing the fluid, knows to not push very fast [so that they] avoid those sharp rising blebs. [They need] to find the right plane and inject slowly. That does contribute to patient comfort.

Urology Times: What is your preferred approach to prophylactic antibiotic use for patients undergoing this treatment? How do you weigh the benefits of preventing infection against concerns related to antibiotic stewardship?

Brucker: Antibiotics around the time of onabotulinumtoxinA need to be tailored to everyone's individual practice and every patient who's undergoing the procedure. What used to be a lot of antibiotic use has turned into a bit more judicious antibiotic use. If we look at the landscape over the past 20 years in medicine, particularly in urogynecology and urology, we don't want to use medications or antibiotics indiscriminately. I still do personally use an antibiotic if it's available and it's the practice, but I don't know that I have data that say my 2 antibiotic pills, 1 right after and 1 [given] 12 hours later, are really having a significant impact.

We'll need to continue to look objectively at these things. We'll need to be critical of the literature that exists. In the paper, [we discussed] the idea that we don't, dogmatically, have to do things the way they were done. After 10 or 20 years of onbotulinumtoxinA experience, you might realize that there are certain things that we were doing that didn't have data behind them, and we were doing them just because. When you start to look at the whole process, giving antibiotics is not a totally benign process or cost-free process. We don't want resistance patterns. We don't want patients to develop [adverse events] from the antibiotics or an alteration of gut flora. There's not a perfect guideline in terms of what we should be doing, but across the board, most of the experts felt like we don't need long-duration antibiotics, but a short, focused bit of antibiotics. [For example,] something that's appropriate for coliform bacteria, the most common [cause] of UTI, would be more appropriate.

Urology Times: After the treatment, what follow-up protocols do you find most effective in ensuring patient satisfaction and treatment adherence?

Brucker: Here, too, we look at our experience. I think the COVID-19 pandemic did give us some insights in terms of [whether we need] patients to come back to check post-void residuals or symptoms. If it's a first-time injection, in my personal practice and I think many out there, we might have someone come back to see how they're doing and to check a post-void residual usually at about 2 weeks. [It’s] not a bad idea to have that touch point. But for my patients who have actually demonstrated, for example, no issues with incomplete bladder emptying, I don't tell them they have to come back for a post-void residual because they've already proven that they're not having an issue. [You can] tell them that if they’re not noticing efficacy, or they're having symptoms that they think might be consistent with incomplete emptying or worsening overactive bladder, they should come in so we can check to make sure they're emptying.

The piece that I think has also been instrumental for many of us that have been using onabotulinumtoxinA for a long time in terms of improving our retreatment rates is scheduling patients for a follow-up at 6 months and not necessarily waiting until their symptoms return. [If they wait until they get symptoms,] then they call the office and it's an unscheduled phone call, and the office staff has more burden. Then [the staff] is trying to get a patient added on. Most of us have waiting lists, and it just delays the ultimate therapy. I liken it to taking a blood pressure medication. You wouldn't say, "I want you to run out of the pill, get high blood pressure, and then need to call your doctor for an appointment to get a prescription to start the blood pressure." It's the opposite of what the ultimate goals are of treating patients with a condition that affects quality of life.

Urology Times: How do you handle patients who experience adverse events following treatment in terms of communication and follow-up care?

Brucker: If a patient does have an adverse event or issues with efficacy, we want to make sure that we find out. That's where the regular follow-up does come in handy, but there are [other] ways of doing that, like having a secure messaging system. We can also do things like follow-up phone calls if needed. Most of those things are not needed, and thankfully, for onabotulinumtoxinA most patients do quite well. But if there is an adverse event or some issue with either the procedure or the post-operative, we need to tailor the next injection or the next therapy. If a patient is having an issue, for example, with more discomfort than they expected right afterward, there may be a benefit of using something like an Azo-type medication to help. [If the patient is] on an anticoagulant, and the clinician had decided to not stop or not hold the anticoagulant, but the bleeding becomes an issue, the subsequent injection or therapy, they might give an option of stopping the anticoagulant.

If there are issues with efficacy, then there are people who will introduce medications, or maybe even consider higher doses or a shorter duration between injections. We almost want to have a cheat sheet for that patient to say, "Hey, this is how they're doing. This is what was really good about their last experience. These were the issues that they were having. How do we improve the patient experience so that they feel not only heard and seen, but we can make certain adjustments medically?" For example, we talked a little bit about urinary tract infections and urinalysis, and maybe not always checking or not being as concerned if they don't have symptoms. If a patient did have a UTI afterward, then we might want to say, "Hey, this time around, let's check a urine beforehand.” We can adapt and tailor as needed to that individual.

Urology Times: Is there anything else that you wanted to add?

Brucker: With the paper, hopefully the readers will have a little bit of insight just on how a group of us think about bringing this effective therapy to our patients. How do we make the patient experience better? How do we improve quality of life? Many of you are experts as well and [administer] this therapy and other advanced therapies for overactive bladder. These were just some things that we had come up with from our experience. I'm sure there are things out there that you are already doing to make your patients much more comfortable. The procedure itself should be very efficient in the office. It should be a very quick thing for the physician, physician assistant, or nurse practitioner to be doing, and it does matter how we say things. We want to make sure that we introduce the therapy early on. The patient experience piece and appropriate follow-up is really what leads people to this effective therapy. Hopefully you enjoy the paper.

REFERENCE

1. Eilber KS, Brucker BM, Pezzella A, et al. Expert opinions on best practices for overactive bladder management with onabotulinumtoxinA. Toxins (Basel). 2025;17(4):207. doi:10.3390/toxins17040207