BackTable / OBGYN / Podcast / Transcript #40

Podcast Transcript: Midurethral Slings vs Bulkamid: What Clinicians Need to Know

with Dr. Tamsin Greenwell

In this episode of the Backtable OBGYN Podcast, host Dr. Suzette Sutherland (University of Washington) and Dr. Tamsin Greenwell (University College London Hospitals) discuss surgical treatments for incontinence and their comparative efficacies. You can read the full transcript below and listen to this episode here on BackTable.com.

(1) Midurethral Sling Options & Considerations

(2) The Mesh Sling Controversy

(3) Shared Decision-Making in Stress Incontinence Treatment

(4) Advances in Urethral Bulking Agents

(5) Long-Term Efficacy & Comparative Studies of Bulkamid

(6) The Role of Bulkamid in Contemporary Incontinence Care

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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

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[Dr. Suzette Sutherland]
Welcome, everyone. I'm your host today, Dr. Suzette Sutherland from the University of Washington. I'm delighted to have Dr. Tamsin Greenwell here from London, across the pond as we say. She's at University College London Hospitals, and she's here to talk to us today about modern surgical treatment for female stress incontinence. Really most specifically, we're looking at comparisons between the much-loved midurethral sling and one of the new urethral bulking agents called Bulkamid. Thank you very much, Dr. Tamsin Greenwell, for being here with us today.

[Dr. Tamsin Greenwell]
It's my pleasure. I'm very excited to talk to you. I talk to you a lot normally, but it's nice to talk to you and have it recorded. [chuckles]

[Dr. Suzette Sutherland]
Right. Dr. Greenwell, as I said, is a consulting urologist in London, University College London Hospitals, and a very good friend, as she just alluded to. We would really like to get a little bit more of a global perspective on this issue. Why don't we start by just telling us a little bit about your practice, and also your involvement in some of the academic societies like BAUS and EAU?

[Dr. Tamsin Greenwell]
Okay. I've been a consultant urological surgeon, which is the equivalent of an attending in the USA since 2002. I'm very old. When I was first appointed in 2002, I was one of nine urology consultants at University College Hospital, and now I'm one of 36. We like to call it Urology College Hospital. I lead the functional, reconstructive, and adolescent urology team, which is composed of six consultants. I've got a completely sub-specialized practice in this area. I only take tertiary referrals, so from other consultants.

My main interests really are female and male urinary incontinence, voiding dysfunction, lower urinary tract fistulae, urethral diverticulum, and stricture in both men and women and low urinary tract reconstruction after radiotherapy and trauma. I've done quite a lot of educational posts, as well as my consultant post. In the past, I've been the Royal College of Surgeons of England urology tutor, setting up and teaching on, and organizing urology skills courses with fresh frozen cadavers and animal tissue.
I've been the BAUS Director of Education. I have led and been the chairperson of the Functional Neuro Urology and Urodynamics section of BAUS. I have been a Board of Director member of the American Association of Urology Genital Urinary Reconstructive Surgeons Society. I've just demitted from that. I'm a committee member for the European Society of Genital Urinary Reconstructive Surgeons. I also sit on the Urethral Stricture Guidelines Committee for the EAU.

(1) Midurethral Sling Options & Considerations

[Dr. Suzette Sutherland]
Needless to say, you know something about the treatment of female stress incontinence. You've certainly lived through your career, the development of many different products. I think you're very well-versed in talking to us today about this topic. I'd like to start with a little bit of a discussion about midurethral slings. Again, both you and I grew up with the introduction of the midurethral sling and how that really changed the way we thought about surgical treatment for stress incontinence.

Because of the different mechanisms of action, the prior procedures that we used, the burch, pubovaginal sling, and other things, the mechanism of action was really at the bladder neck. Here we had something, which placed the mechanism of action at the mid urethra, thus the name, midurethral sling. Can you speak to that a little bit more in your experience with the first one that came out, what that was, and how that worked?

[Dr. Tamsin Greenwell]
It was really devised from Petros and Ulmsten's theory that a significant amount of continence in the female is dependent on the anatomical interrelationship with the anterior wall of the vagina. I like to think that it's all about the vagina. They devised a way of providing a backstop to prevent the urethra opening and leaking during stress and exercise and exertion by supporting the urethra posteriorly and anchoring it towards the anterior aspect of the vagina with the retropubic synthetic midurethral sling. Because it was simple and effective, it revolutionized the treatment of stress incontinence in women, becoming a day case procedure from when it was devised in 1996.

[Dr. Suzette Sutherland]
Since that time, it has been a great procedure. We had great efficacy. I think the longest-term data we have is on the retropubic sling. As you well know, it goes out about 20 years, showing great safety and efficacy out to the high 80%, low 90% at 20 years. That's really wonderful. We know that it really works well for those it works well in, and it continues to work well over the years.

There were reiterations as innovation happened to say, "How can we continue to maintain the same efficacy with the midurethral sling but maybe improve the safety guidelines or the safety profile a little." That's how the transobturator came about. Then following that, the single incision sling. What were your experiences with those?

[Dr. Tamsin Greenwell]
Delorme invented the transobturator synthetic midurethral sling in about 2001. The aim was to try and avoid the risk of bladder perforation and hence the need for cystoscopy and make it a quicker procedure and less costly. Unfortunately, that hasn't proven to be the case. You still need to do a cystoscopy because you can still perforate the bladder, although not as commonly as when you do a retropubic synthetic midurethral sling. The mini-slings were devised to try and avoid traversing the obturator fossa to try and reduce the risk of groin pain, which is a rare but significant complication associated with a classic transobturator synthetic midurethral tape.

I do use the term synthetic midurethral sling to try and distinguish from autologous midurethral slings, which have developed following the mesh controversy with the autologous sling being sighted around the midurethra rather than the bladder neck, which was how they were cited classically. The aim of these synthetic slings is really to have no tension, no occlusion of the urethra, to simply sit loosely around the urethra, but provide a rigid backstop, as I said before, but they must never be inserted into tension.

[Dr. Suzette Sutherland]
Right, and that's a big key component and a big difference between the bladder neck procedures and the midurethral procedure. Absolutely, that it provides for this sort of dynamic kinking at the level of the midurethra as the woman is dynamically moving, doing a stress maneuver. What we do see today is, before we get into some of the mesh hoo-ha, we'll touch on that. What we do see today is that there's enough data that's in our literature, looking at randomized control trials, comparing the retropubic slings, the efficacy, and safety to the transobturator, to the single incision slings, showing equal efficacy in trained hands.

People who appreciate the differences between them and how to tension that differently so that they're not too tight, but still efficacious, that the efficacy really is comparable, such that our American Urological Society and our Society of Urodynamics, Female Urology, our guidelines for treatment of index stress incontinence now includes the possibility of doing either one of these three slings equally. They did an update just this year, in 2023, acknowledging that there's way more data now in our literature in the form of randomized control trials and showing equal efficacy. I think it really comes down to what's good in your hands, what you're comfortable with, and where you're getting your efficacy.

[Dr. Tamsin Greenwell]
I'm going to have to disagree with you slightly there. I hate to do this, Suzette, being as we're such good friends.

[Dr. Suzette Sutherland]
No. That's why we have you here.

[Dr. Tamsin Greenwell]
If you look at the long-term data, the EAU guidelines have quite clearly stated that whilst there's short-term equivalence, there isn't in the long-term. In the long-term, there's an advantage over a retropubic synthetic midurethral sling over a transobturator. There is no long-term data on the mini-slings. Whilst they're equivalent in the short-term, the Al-Fattah randomized trial was out to 15 months only. They're not the equivalent in the long term because we don't have that data. They're also associated with different side effect profiles.

There was a higher, if you look at the Al-Fattah randomized control trial, looking at mini-slings versus classical slings, which were unspecified whether they were retropubic or transobturator, they were a mix according to surgeon preference. There was a higher need for recurrent surgery for stress incontinence, 2% as opposed to 1% for the mini-slings, and a higher incidence of dyspareunia. I think for me, the jury's still out on mini-slings.

There is, in my mind, equivalence for the retropubic and the transobturator in the medium term and in the long term, the woman in front of you has to decide whether she wants to go for cure of her stress incontinence at the risk of higher voiding dysfunction in the long term with a retropubic or a lower risk of voiding dysfunction and a slightly lower risk of cure of stress incontinence with the transobturator.

[Dr. Suzette Sutherland]
Right. Again, we have a situation where the data just isn't there. We don't have really long-term randomized controlled trials with a single incision sling. Certainly not out to 10 and 20 years. Of course, we don't have that because it was first developed in 2008. I think what we see in the relatively speaking short-term, three to five years, looks rather comparable, but you're absolutely right. We need more data that actually takes us out to that long term so we can make some educated decisions about that.

(2) The Mesh Sling Controversy

[Dr. Suzette Sutherland]
Let's talk a little bit about the mesh issue. I like that you say you keep saying synthetic mesh sling. I say that too, when I talk to patients so they understand what am I talking about. Because then they always ask, "Well, isn't that the sling, the mesh that had problems?" So on and so forth. Yes, we all lived through that, but here in the United States, we didn't live through the same kind of pause that you had in the UK in 2018. Can you talk a little bit about that and what that did and where you are now in the UK with respect to the use of mesh?

[Dr. Tamsin Greenwell]
Yes, certainly. As I said before, with synthetic midurethral sling, they were perceived as quick, effective, and complication-free. They are indeed quick and effective, but they're not complication-free. They have the same complications as all-surgical procedures and like wound infection, blood clots on the legs that can go to the lungs, chest infections. They've got the same complications as all surgical procedures for stress incontinence, which is failure to cure the stress incontinence in 10 to 20%, the need to self-catheterize because of voiding dysfunction in between 1 and 4% depending on the procedure, and new onset frequency urgency.

They've also got some specific mesh-related complications, which occur rarely but are significant. There's mesh exposure in the vagina. I'm using the IUGA classification here. Mesh extrusion into the urethra and the bladder. Mesh extrusion into gastrointestinal organs and chronic pain persisting for more than 6 months that is related to mesh, in particular the groin and the suprapubic pain that can come after transobturator or retropubics. There was an increasing awareness of these complications following the 2008 FDA notification in the UK and patient groups were formed for mesh-injured patients with those complications. The largest patient group is called Sling the Mesh, which has more than 7,000 members.

It conducted a survey of about 550 of its members and found that contrary to the FDA notification which talked about complications associated with vaginal mesh prolapse, more than 75% of the Sling the Mesh members had a synthetic midurethral sling for incontinence and more than 75% of them suffered from chronic pain. This raised awareness, led to various national and international reviews from Scotland, England, and the European Union and a formal public review led by Baroness Cumberlege which announced a high-vigilance pause on the use of synthetic mesh for urinary incontinence in 2008. The review has now been completed. It issued a report that's been published.

The conditions for recommencement of synthetic midurethral sling usage are that they should only be inserted by appropriately trained surgeons, which makes sense, who have undertaken a regular volume of operation, which means that they maintain their expertise, that they need to report every procedure for stress incontinence including synthetic midurethral slings to a national database, and keep a registry so that any complications are noted and acted upon early, a bit like the hip-knee joint replacement registries we've got, that all complications need to be reported to our equivalent of the FDA, which is called the MHRA, and that specialist centers for mesh procedures, insertion and removal need to be bid for and set up within the United Kingdom, that NICE guidelines, which is our equivalent of the American Urology Association, National Institute of Clinical Excellence, need to be revised and be issued on the use of mesh and all of those six conditions need to be met before synthetic midurethral slings can be reintroduced for stress union incontinence.

To date, most of them have been met. NICE has issued guidance and it does recommend retropubic synthetic midurethral slings. It says that transobturator midurethral slings should only be utilized in specific cases because of the difficulty in removing them if patients have complications and that mini-slings can't be recommended because of only the lack of long-term follow-up data. It does also recommend that along with retropubic synthetic midurethral slings, colposuspension, and autologous midurethral slings are offered along with bulking agents for women who have failed lifestyle modifications and pelvic floor muscle training. The only thing we're outstanding at the moment is the registry in the database. It's in progress but it's not complete yet.

[Dr. Suzette Sutherland]
That was a wonderful overview of what happened and what the response was. I want to take a step back though and just really ask you and in your own personal practice, what you started off by saying is the number of reports of chronic pain in patients that had a midurethral sling. It was 70 to 75 % I think is what you said, and that's what grabbed the attention and why this pause happened and then the investigation into this. In your practice, is that what on a regular basis, and then can you really say that it was the mesh sling that was the source of the chronic pain in these women? It's really hard to tease out.

BAS conducted a prospective study of all stress urinary incontinence procedures over a period which is published in the BJU International. What it showed was a persistent pain following transobturation retropubic synthetic midurethral slings occurred at six months in about 2 to 3% of patients, which is a low number you would agree. It's a very low number although of course if it's a chronic pain issue for that individual, it's a big problem. It's a very low number when we look at other procedures we do, look at the high number percentage of complications we accept when we place an artificial urinary sphincter for example. Just to throw that in the discussion.

[Dr. Tamsin Greenwell]
I think that there is an unrealistic idea about the level of complications associated with most surgery. For example, there was a study looking at 95,000 primary synthetic midurethral slings placed in England from HES data, and over a nine-year period, there was a 9.8% perioperative and up to five-year complication rate. Patients reattended hospital or accidentally emergency departments with complications that although they don't know and can't specify the complications. It could be difficulty with bladder emptying. It could be a UTI. Or it could be chronic pain or mesh exposure or extrusion. It's really difficult to quantify.

I would say that 9.8% is actually quite a low overall complication rate, but this was held up as being a significantly high complication rate. If you look at something comparable, or something completely different, if you look at a cystectomy or a clam cystoplasty - the complication rate, if you look at overall at wound infection, need to self-catheterize, and UTIs, is much higher. It's all about people being truly aware of the complication rates of surgery. There's also chronic pain post-surgery is just becoming something that we as surgeons are aware of. If you look at, there's a nice paper that shows chronic pain after cesarean section happens in 5.8% of women.

When we looked at our colposuspension and rectus fascial sling data for the BAUS paper I talked about, the chronic pain at 6 months was much higher for the big operations. It was about between 6 and 12%. There is an issue with ongoing discomfort and pain post-surgery. We do know certain groups of patients are at higher risk. Those who have underlying chronic pain, conditions like ME or fibromyalgia. Those who have associated depression. There are groups of patients that we can now warn are more likely to develop chronic pain following any type of surgery really. That is something I think that we as surgeons have only really become aware of since the mesh debate began.

[Dr. Suzette Sutherland]
Yes, what you're saying, maybe it's not the best word to use, but I call it the insult of surgery. Meaning it's the trauma, relatively speaking, of the surgical procedure and not necessarily the mesh itself, which is responsible for the chronic pain. There are some patients that we can get some operative indication if they might be one of these people, but sometimes we don't at all. With that, all of the exposure and media around pain issues with anti-incontinence procedure than in general, I think there are a lot of women who are now going back into the closet, so to speak, and not seeking the care in order to resolve their issues. Are you seeing the same thing?

[Dr. Tamsin Greenwell]
Yes, there was a massive drop-off in women seeking stress incontinence procedures. Can I just take a step back and go to the issue of pain after synthetic midurethral slings again? I think there are two types of pain. There is a woman who wakes up with pain and has pain in the distribution of, say, the obturator or around the groin or around the suprapubic area. If you palpate the mesh, you can reproduce the pain, and that, I think, is quite clearly related to the pain. Then there's another more difficult group who have diffuse or generalized pain. That may have started off as the former and progressed, but it may be part of a generalized pain syndrome. It's actually very difficult to tease out.

In terms of what happened is that women became frightened, and they didn't seek treatment. They stuck with conservative methods or just containment. We know that stress incontinence affects about 20% of women perimenopausally between the age of 46 to 60. Even if I do say so myself to you, Suzette, it's the prime of their lives. We know that stress incontinence significantly adversely affects mental and physical well-being.

It's got negative effects on intimate relationships, on the ability to work. It's really difficult to teach if you're hoochingly wet into pads. Because of the breakdown of relationships, the inability to work effectively, it also affects the financial status. It's also costly. Pads cost in excess of £100 a month, $130 a month at least, so it really has a negative impact on women. I feel so sad if they're sitting at home coping because they're frightened of side effects.

(3) Shared Decision-Making in Stress Incontinence Treatment

[Dr. Suzette Sutherland]
Yes, so this takes us into another topic just briefly. I want to talk about this concept about shared decision-making. I know you and I have had conversations about this, and it's such a buzzword today, "We need to be having shared decision-making with our patients." I would argue that we always did. We always would tell patients the risks and benefits of a surgery and then help guide them where guidance was necessary.

When we talk about shared decision-making, sometimes people just provide a patient with all of the options and now say, "Here's your platter, you choose. It's a smorgasbord, and you choose what you want." Do you think in that pure sense that that's really fair to the patients? What's our role to help guide those patients, and what do you do?

[Dr. Tamsin Greenwell]
I think it very much needs to be individualized towards the woman sitting in front of you. Some women will want you as the doctor to guide them to what you think is best. Some women will want to have an in-depth discussion about what their aims are from the surgery and what the side effects are that they completely risk to avoid. Some women will say, "I do not want to self-catheterize whatever happens." Other women would just want to be dry, and some women would be happy with just being a little less wet.

Really it's about individualizing your consultation, but actually, I do feel that the woman sitting in front of you needs to be told about, know about, all of the options that are available to them, and the pros and the cons, and how they fit in with what their aims in terms of treatment successes and avoids are. It's actually law in the UK that you've got to do that. A stress incontinence consultation, you have to talk about doing nothing to having an ileal conduit.

It doesn't mean that you just give them the information, give them the leaflets, and let them walk off, but you do need to make sure that they're fully informed. It's difficult because the concept of fully informed, we've talked about this before, only you and I could perhaps give fully informed consent to the procedures that we do. We can at least make sure that the woman in front of us is understanding us as much as they're able to make an informed choice and decision.

[Dr. Suzette Sutherland]
I think you've made the analogy before to a car mechanic. I take my car in and it's making some funny noises. I don't want to know everything about how an engine works; I just want you to fix it. Hopefully, we're not at that level when we're talking to our patients, but I think truly what you said, if you're giving a woman who has straightforward stress incontinence all of the options, all the way up the algorithm to an ileal conduit and the risks and benefits associated with that, that's got to be a conversation that takes several hours.

It becomes too much information for the patients to be able to really process in an educated way. Yes, I think some guidance is helpful. You did also point out two things, which we've had this conversation before too, which I thought was really helpful to break it down. What does the patient want and what does the patient want to avoid? Those two real questions really help guide your discussion with the patients and the patient with you.

[Dr. Tamsin Greenwell]
It may be that what they want is to not be off work and to have minimal recovery time, in which case you'd say, "Well, bulking's for you." It may be that they want something that's got the best outcomes in terms of stress incontinence cure, in which case the estro-meta-analysis would suggest that's an autologous rectus fascial sling or a tensor fascia lata sling. It may be they want something that's very effective, almost as effective as the autologous sling, but with a quick recovery. That would be a synthetic midurethral sling. I do think that really helps you with your discussions.

[Dr. Suzette Sutherland]
Absolutely. I think that is an important thing. Just what we think is important as far as an outcome isn't necessarily what's important to the patient. That's where we need to be listening to them and helping them with the-- that's where the shared decision-making comes in, I think.

(4) Advances in Urethral Bulking Agents

[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? 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. 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.

Long-term studies have shown that there doesn't seem to be a significant fibrotic reaction to the injection, that the volume stays virtually the same. 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]
The other advantage I would say that you alluded to as well is because of the carrier type of gel, I say, "What is what you get." When you make a blab and you take the needle out, it doesn't come back out at you. I think you really have more of a reliable injection. You feel more confident that you made a difference, that the patient isn't going to wake up and maybe bear down and squeeze all of the product back out the little holes. It actually stays where you put it. I feel like it's more reliable.

(5) Long-Term Efficacy & Comparative Studies of Bulkamid

[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.

[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.

(6) The Role of Bulkamid in Contemporary Incontinence Care

[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.

[Dr. Tamsin Greenwell]
Thank you.

Podcast Contributors

Dr. Tamsin Greenwell

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

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.