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Midurethral Sling Procedure: Is it Safe?

Author Grace Dima covers Midurethral Sling Procedure: Is it Safe? on BackTable OBGYN

Grace Dima • Jul 1, 2024 • 31 hits

The midurethral sling has revolutionized stress incontinence treatment, proving to be effective and safe over the long term, with ongoing procedural innovations. However, sling treatment is not without risks. Over recent decades, patient advocacy groups have highlighted issues such as chronic pain and mesh complications following midurethral sling procedures, leading many women to hesitate in seeking these interventions for their stress incontinence. It is important for clinicians to help patients understand the risks and benefits of various stress incontinence treatments, enabling them to make well-informed decisions and achieve satisfactory outcomes.

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

• Retropubic slings are highly effective for long-term treatment of female stress incontinence with success rates of 80-90% over 20 years. However, the procedure carries risks such as voiding dysfunction and bladder perforation, which necessitate cystoscopy during the procedure.

• Transobturator slings reduce the risk of bladder perforation but may cause groin pain and have slightly lower cure rates. Mini-slings offer comparable short-term results with less risk of groin pain but lack long-term data.

• Chronic pain occurs in about 2-3% of midurethral sling patients at six months post-procedure. While relatively low, it is significant for affected individuals.

• The UK patient advocacy group, Sling the Mesh, highlighted chronic pain and other complications from synthetic slings, and significantly influenced the NICE guidelines regarding midurethral slings. NICE guidelines recommend retropubic synthetic midurethral slings as a preferred option while reserving transobturator slings for specific cases due to removal difficulties if complications arise. Mini-slings are not recommended by NICE due to insufficient long-term data.

Midurethral Sling Procedure: Is it Safe?

Table of Contents

(1) Advances in Midurethral Slings

(2) The UK Mesh Controversy & Its Impact on Midurethral Sling Practices

(3) Shared Decision-Making in Stress Incontinence Treatment

Advances in Midurethral Slings

The midurethral sling, introduced in 1996, revolutionized the treatment of female stress incontinence by shifting the focus from the bladder neck to the mid-urethra. The sling supports the urethra via the anterior vaginal wall, preventing leakage during stress or exertion. The retropubic sling, the first midurethral sling introduced, has shown high safety and efficacy rates (80-90%) over 20 years in long-term data.

To improve safety and efficacy, innovations followed the initial midurethral sling. While the retropubic sling is effective, it carries a risk of voiding dysfunction and bladder perforation, necessitating cystoscopy during the procedure. In response, the transobturator sling was developed in 2001 to reduce this risk and simplify the procedure. Although it still requires cystoscopy and carries a lower risk of bladder perforation, the transobturator sling has a lower risk of voiding dysfunction but slightly lower cure rates for stress incontinence and a rare but significant risk of groin pain.

The single incision sling, or mini-sling, was designed to avoid the obturator fossa, thereby reducing the risk of groin pain associated with the transobturator sling. It shows comparable short-term efficacy to both retropubic and transobturator slings. However, it lacks long-term data, with current studies covering only up to 15 months.

[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.

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
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The UK Mesh Controversy & Its Impact on Midurethral Sling Practices

The UK mesh controversy arose from complications linked to synthetic midurethral slings, such as mesh exposure, extrusion, and chronic pain. Awareness increased following the 2008 FDA notification, leading to the formation of patient advocacy groups like Sling the Mesh. A survey revealed that over 75% of members with synthetic slings experienced chronic pain, prompting national reviews and a 2018 pause on mesh use.

To resume the use of synthetic slings, several conditions were established: surgeons must be properly trained on the procedure, perform regular operation volumes, ensure national reporting, and operate within specialist centers. The NICE guidelines, the UK equivalent of the American Urology Association's National Institute of Clinical Excellence, now recommend retropubic slings and also suggest offering colposuspension, autologous midurethral slings, and bulking agents for women who have failed lifestyle modifications and pelvic floor muscle training. Transobturator slings are reserved for specific cases due to the difficulty of removal if complications arise, and mini-slings are advised against due to insufficient long-term data.

Overall, chronic pain occurs in about 2-3% of patients with midurethral slings at six months post-procedure. Dr. Suzette Sutherland notes that this complication rate is relatively low compared to other surgical interventions for stress incontinence, such as artificial urinary sphincter placement. However, for those affected, the complications significantly impact their quality of life. A study of 95,000 midurethral slings in England revealed a 9.8% perioperative and five-year complication rate. Dr. Tamsin Greenwell points out that these complications were not well defined in the study and may include bladder emptying issues, UTIs, chronic pain, and mesh exposure or extrusion, making it difficult to quantify the true complication rate.

[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 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.

Shared Decision-Making in Stress Incontinence Treatment

Fear of complications has led many women to avoid seeking treatment for stress incontinence, opting instead for conservative methods or containment. This is concerning as stress incontinence affects about 20% of women aged 46 to 60, impacting intimate relationships, work ability, and financial status due to the high cost of pads. This reluctance can significantly diminish their quality of life.

To address this issue, shared decision-making should be personalized to each patient. Some women prefer clear guidance from their doctor, while others favor in-depth discussions about surgical options, goals, and risks. In the UK, it is legally required to discuss the full range of treatment options, from doing nothing to invasive procedures. However, providing every detail can be overwhelming. The key is to balance comprehensive information with the patient’s ability to process and use that information effectively.

Effective shared decision-making involves understanding the patient’s priorities and helping them navigate their options based on their needs and preferences. For example, a patient seeking minimal recovery time might consider bulking, while one aiming for the best outcomes might opt for an autologous sling. This personalized approach enables patients to make informed decisions about their health, addressing both immediate and long-term concerns.

[Dr. Tamsin Greenwell]
In terms of what happened is 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.

[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.

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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