Bulkamid: A Less Invasive Option for Urinary Incontinence

[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?

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[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.

[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.