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Bulkamid: A Less Invasive Option for Urinary Incontinence

Author Grace Dima covers Bulkamid: A Less Invasive Option for Urinary Incontinence on BackTable OBGYN

Grace Dima • Jul 9, 2024 • 32 hits

Bulkamid is a urethral bulking agent for urinary incontinence treatment that has only recently been approved for use in the United States. Unlike older urethral bulking agents that had mixed results and cumbersome procedures, the innovative Bulkamid procedure provides a more effective and precise solution according to consultant urologist Dr. Tamsin Greenwell. Long-term European studies, where Bulkamid has been used since 2006, demonstrate high patient satisfaction over a seven-year follow-up. Although its efficacy is objectively lower than other surgical interventions like midurethral slings, Bulkamid remains a viable, minimally invasive treatment option, making it an appealing choice for many patients.

This article features excerpts from the BackTable OBGYN Podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.

The BackTable OBGYN Brief

• Bulkamid is composed of a non-degradable, homogenous polyacrylamide gel, which distinguishes it from older urethral bulking agents.

• Unlike older urethral bulking agents that required long cystoscopes, the Bulkamid application technology includes a short urethroscope with a special needle guide.

• Long-term studies from Europe report that over 80% of women experience significant improvement in stress urinary incontinence with Bulkamid, with 30-35% achieving complete dryness after seven years.

• Approximately 43% of patients may require a second Bulkamid injection within 1-2 months following the initial treatment for optimal results.

Bulkamid: A Less Invasive Option for Urinary Incontinence

Table of Contents

(1) How Bulkamid Improves on Previous Urethral Bulking Agents

(2) Bulkamid Efficacy

(3) Discussing Bulkamid with Patients

How Bulkamid Improves on Previous Urethral Bulking Agents

Historically, urethral bulking agents had mixed results; previous gels were either degradable, like collagen, or particulate, where particles in a carrier gel would either dissolve, leaving behind hard particles, or gradually dissolve entirely, as seen with agents like Deflux. These older methods often required long cystoscopes, making the procedure cumbersome and less precise. In contrast, Bulkamid, a non-degradable polyacrylamide gel, features a short urethroscope with a special needle guide for easy and precise submucosal injections. This creates effective suburethral bulges that support the sphincter, reducing the need for repeat injections.

[Dr. Suzette Sutherland]
That's a nice segue into these urethral bulking agents. Other options for incontinence. As I said, there's a newer kid on the block called Bulkamid. Historically, the urethral bulking agents have, they've had their role, but they've worked so-so. About a third of the patients are resolved, a third better, a third fail, requires repeat injections, so on and so forth. With Bulkamid, our experience is that things are really quite different.

It's working really quite well and not necessarily requiring the expectation of repeat injections. Can you tell us a little bit more about it and why this product is really working better?



[Dr. Tamsin Greenwell]
How it differs is it's a non-degradable, non-particular, homogenous gel. It's composed of polyacrylamide. Before that, the gels were either degradable, if they were homogenous, like collagen, or they were particulate. They were particles in a carrier and the carrier would dissolve and it would leave the hard particles behind or there would be gradual dissolution of the whole particle as in deflux. The other thing the manufacturers did with Bulkamid is they created an amazing bit of kit to allow you to inject into the female urethra.

It's a very short urethroscope with a special needle guide that allows you to just place the injection under the submucosa and give you quite nice submucosal, suburethral bulges to actually assist the sphincter in coaptation. We didn't have that before with the other types of injectors, injectables. We had to use very long cystoscopes, and it was a bit like trying to eat your dinner with very long chopsticks through the letterbox. I think that bit of care, along with its ease of use because it's a gel and relatively simple to inject, have made a big difference in how it's perceived in its uptake.

Listen to the Full Podcast

Midurethral Slings vs Bulkamid: What Clinicians Need to Know with Dr. Tamsin Greenwell on the BackTable OBGYN Podcast)
Ep 40 Midurethral Slings vs Bulkamid: What Clinicians Need to Know with Dr. Tamsin Greenwell
00:00 / 01:04

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Bulkamid Efficacy

Bulkamid, approved by the FDA in 2020, has been used in Europe since 2006, providing extensive long-term data. Studies show that Bulkamid injections cause minimal fibrotic reactions and maintain their volume over time. However, distinguishing Bulkamid from a urethral diverticulum on an MRI can be difficult. In such cases, Dr. Greenwell recommends a transvaginal or transrectal ultrasound to identify the cross-hatching of Bulkamid particles.

Efficacy trials, including a seven-year European study, indicate that over 80% of women experience significant improvement in stress urinary incontinence, with 30-35% being completely dry at seven years. Around 43% of patients may require a second injection within 1-2 months for optimal results. While not as effective as midurethral slings, Bulkamid offers high patient satisfaction and remains a viable treatment option.

[Dr. Suzette Sutherland]
First of all, it's been around in Europe much longer than here in the United States. It was FDA-approved in early 2020. Our experience here has just been since then, but we look at the European data, of course, an experience has been around for a much longer time.

[Dr. Tamsin Greenwell]
It's been in use since 2006, but I think that was the first report of its use.



[Dr. Tamsin Greenwell]
There is a bit of difficulty in telling Bulkamid from a urethral diverticulum on an MRI. If there's any doubt whether it's a diverticulum or Bulkamid, then I would advise to get a transvaginal or transrectal ultrasound as you can see cross-hatchings of the particles. It seems to be a safer form of bulking that also seems to be extremely effective. Not as effective as the classical treatments for stress urinary incontinence, but nearly.



[Dr. Suzette Sutherland]
As you already said, the blebs seem to stay there over a long period of time and those that have been imaged, so we know that as well, and seems to be working well. With that in mind, the first studies that have been done and some longer, there's a seven-year long-term study out of Europe that looks at the efficacy of the Bulkamid. Can you speak to that?

[Dr. Tamsin Greenwell]
Yes, there's been a five-year and a seven-year study performed. They basically show similarly that you get more than 80% of women at those time periods say that they're cured or significantly improved in terms of their stress incontinence. If you look at the seven-year data paper, it breaks it down into cured as in dry and improved. In terms of dry, 30 to 35% are dry at seven years, but more than 80% say they're dry or improved and happy.

[Dr. Suzette Sutherland]
Yes, if you break that down, then that's, 30% that are dry, so we would say cured and the other 50%, would be improved in the improved category. Thank you for breaking that down. I think it's just important when we're counseling patients, what we tell them. Regardless, 80% of the patients are quite happy because, in their mind, significantly improved. Then the number of patients that we see in some of the studies, that in order to get that, about 43% of the patients require a second injection after about a month or two months or so. Is that the case in these studies as well where in order to get that efficacy?

[Dr. Tamsin Greenwell]
It's not really detailed very well in those longer-term studies. The data with the 43% re-injection rate is from [unintelligible 00:31:51] group in Finland, who did the prospective randomized control trial, randomized trial between Bulkamid and retropubic synthetic midurethral slings, the classic TVT. I think actually the company that manufactured Bulkamid did a very brave and honorable thing in that they gave the funding to Professor [unintelligible 00:32:13] department to do this study, but they had no control over its design, the conditions, or the data.

They put their money where their mouth is in terms of their product. While it's shown that Bulkamid does not cure stress incontinence as well as a TVT, it has shown high levels of patient satisfaction and significant cure in terms of stress incontinence such that it remains on the table as an option for primary treatment of stress incontinence.

Discussing Bulkamid with Patients

Bulkamid is a valuable option for treating stress urinary incontinence and should be included in a shared decision-making discussion to help patients choose the best treatment for their needs. According to NICE and EAU guidelines, surgical options like Bulkamid should be considered only after lifestyle modifications and pelvic floor muscle training have failed.

A three-year randomized control trial indicates that synthetic midurethral slings offer higher objective efficacy, with a 95% success rate compared to Bulkamid's 66-70%. Subjectively, 95% of sling users reported significant satisfaction, while Bulkamid users reported 60% satisfaction. The choice between these treatments depends on patient preferences: whether they prioritize complete dryness with potential mesh complications from slings or prefer the less invasive Bulkamid, accepting possible additional injections or slight leakage.

[Dr. Suzette Sutherland]
Yes, that's a good segue into the comparative trial, the randomized control trial. It went out one year and then they extended it out a few more years to three years. Looking at the data there, as you already alluded, the retropubic midurethral sling is the one that they used, showed improved objective efficacy with a negative cough stress test and pad weight test as defining, objective success and out to 95%. Whereas with the Bulkamid, it was more in the 66, so high 60s, low 70%. That's what we often see with bulking agents.

They use a different type of evaluation for subjective assessment, a scale that went from 0 to 100 and identified that everybody that said that they were 80 or above was significantly subjectively improved. When we look at that, the percentage of patients in the sling group who said that they were 80 or above, so satisfied, were 95% compared to 60% in the urethral bulking agent group, which is then different when we're looking at some other numbers that we see. I guess one of the take-homes really of this is when we look objectively, again to our point about shared decision making, what does a woman really want?

Does she want to jump on a trampoline and not have to worry about doing high-impact activity? Her really primary goal is to be dry, then perhaps counseling her about a midurethral sling is going to be the thing that'll get her there, acknowledging that there are some issues. You already said 1 to 2%, less than 5%, so on and so forth in trained hands for some of the mesh complications, compared to, "Okay, you won't be completely dry, jump on a trampoline, but is that good enough for you and your quality of life? Then avoid any of the potential complications associated with mesh."

[Dr. Tamsin Greenwell]
Yes, you can tailor it to that, but you could also turn it on its head and say, "If you have one or two injections of Bulkamid, you've got a 60% plus chance of being dry after 3 years." There's no long-term data just like there've been these things, but there is some data suggesting that if you fail the bulking agent, Bulkamid, then you could progress to have a synthetic midurethral sling without any adverse effect on your final outcome.

It's really whether the woman sitting in front of you wants to have the least invasive procedure and accepts the second one, should she not be dry, or is happy to leak a little, or whether they want to go for perfect. I do think it's quite a different patient population in terms of the choices that are made.

[Dr. Suzette Sutherland]
Yes, and so that brings me to my next question, as far as that's concerned, is then how do you use this in your practice? We have very different treatment options that provide seemingly good satisfaction depending on what the patients really are looking for, and where do you see using this in your practice?

[Dr. Tamsin Greenwell]
As per NICE guidance and the EAU guidance, if a patient's tried and failed lifestyle modification, losing weight to a BMI of less than 35, completed treatments of supervised pelvic floor muscle training without benefit, then I offer and discuss all available surgical options. For example, if you've got no hypermobility, you've got intrinsic sphincter deficiency, then a colposuspension isn't on the table for you. If you've got stress incontinence and you've got a history of pelvic radiotherapy, I personally don't think a synthetic midurethral sling is on the table for you, and possibly intraurethral bulking because of the associated risks of exposure and extrusion.

If all options are on the table, then you need to discuss everything, as I said, from doing nothing to ileal conduit. As I say, it's a realistic discussion, starting off with what would they like, what would they like to avoid. Most, the vast majority of women, you get to the stage where you say, and there's also something called a bladder neck artificial urinary sphincter that's a more invasive operation or an ileal conduit with a bag, and they say, "I'm not interested in that." You don't spend a huge amount of time going into every single detail of every single operation because they're quite clearly not interested in the more major operation, which is entirely sensible and expected.

They want to concentrate talking about, "Well, what are the differences in terms of success, recovery, and complications of bulking, synthetic midurethral sling, autologous fascial sling, and colposuspension if they've got hypermobility." That's mostly what you spend your time talking about. Then we give them a detailed letter and patient information leaflets from the BAS, and then we let them go away and think about it, talk about it with family, and then come back and make their decision.

[Dr. Suzette Sutherland]
Right. There is, you already alluded to it as well, and I just want to point it out there again and just say you gave a nice summary there of how you talk to patients and what the options are. There is a big movement right now that all women should be offered the Bulkamid as their primary treatment for stress incontinence. Then as you already said, if it doesn't work, you can go ahead and progress on to a midurethral sling. Just to complete the story, the opposite is also true of someone to do a midurethral sling and not get quite the efficacy that they wanted. You can always add some bulking agent without impunity, just to have completed that statement.

Regardless, what do you think about this idea that maybe the guidelines might get changed to say, "Everyone needs to be offered a urethral bulking agent, whether they have urethral hypermobility or not, and if they fail, then a midurethral sling." I think some of this argument is coming again from the mesh naysayers who are worried about complications of mesh. As we went through earlier in this discussion, there are mesh complications, but they really are very low percentages when we look at other procedures that we do and what percentages complications are there.

[Dr. Tamsin Greenwell]
I think to dictate the procedure that a woman has by changing pathways is wrong. It's their body, their decision, their choice, what they want to achieve and avoid. To make it that Bulkamid is the first step as a gatekeeper is inappropriate. It's being paternalistic or maternalistic as medicine becomes feminized. I do think we have to have this joint discussion with the woman sitting in front of us to work out what's the best procedure for her. They may want a one-and-done. If they want a one-and-done, that's relatively minimally invasive, then they would go for a synthetic midurethral sling.

If they want, as I said, the absolute best in curing stress incontinence and aren't bothered about side effects, then they might go for an autologous sling. Really to place Bulkamid as an essential step prior to progressing isn't appropriate. Interestingly, the mesh-injured patient groups in the UK are very suspicious about bulking agents, as they're an additional foreign body. You've also got a group of women who aren't interested in that. We need to advise people about everything.

[Dr. Suzette Sutherland]
Right. Yes and then with that, can you just for the audience say what are the EAU guidelines at this point? Of course, counseling women about their options but with respect to the bottom line, what are their recommendations from the EAU about slings versus Bulkamid?

[Dr. Tamsin Greenwell]
They very much specify and reiterate that they have to be offered a choice of different surgical options and a discussion of pros and cons. The three main procedures they recommend are synthetic midurethral slings, either by retropubic transobturator or mini, but with the provisos that I said about long-term data, and the autologous fascial slings and colposuspension either laparoscopic or open. They say that bulking agents can be offered to women who are seeking a low-risk procedure on the understanding that the efficacy is lower in terms of cure of stress incontinence. They may need repeat injections, and there's little data on long-term outcomes.

[Dr. Suzette Sutherland]
Yes, one of the things that came out of the three-year comparative trial between the sling and the bulking agent, Bulkamid, was they said that high subjective satisfaction does not seem to always require complete objective cure. I think as surgeons, we're always trying to see how we can give them the most efficacious answer to their problem. Again, back to this idea of shared decision-making, that's not always what the patient wants. I think it's really important to identify that and help guide the decision from there, so great. I think this has been a wonderful lively discussion. I think we hit all the points that I was interested in. Is there more that you had in mind?

[Dr. Tamsin Greenwell]
No, I just really think that it's important to maintain and expand our armamentarium if you don't offer everything personally, to have a linked network that if the woman says to you, "I'd like to have a laparoscopic colposuspension," I don't do that. I refer to my gynae colleagues. I think it's important to offer every option and to refer on if you can't offer that. That way I think you have good care.

[Dr. Suzette Sutherland]
Very good point. Yes, you need to know who's in your community and who does what, and who to refer to if a patient wants something that you don't feel comfortable doing. That's a very, very important point.

Podcast Contributors

Dr. Tamsin Greenwell discusses Midurethral Slings vs Bulkamid: What Clinicians Need to Know on the BackTable 40 Podcast

Dr. Tamsin Greenwell

Dr. Tamsin Greenwell is a consultant urological surgeon at University College Hospital at Westmoreland Street in London, England.

Dr. Suzette Sutherland discusses Midurethral Slings vs Bulkamid: What Clinicians Need to Know on the BackTable 40 Podcast

Dr. Suzette Sutherland

Dr. Suzette Sutherland is the director of female urology with UW Medicine in Seattle, Washington.

Cite This Podcast

BackTable, LLC (Producer). (2023, December 6). Ep. 40 – Midurethral Slings vs Bulkamid: What Clinicians Need to Know [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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