Urology Times Innovation Celebration: Expert Insights - Episode 5
Urology Times® is celebrating its 50th anniversary in 2022. To mark the occasion, we are highlighting 50 of the top innovations and developments that have transformed the field of urology over the past 50 years. In this installment, Howard Goldman, MD, discusses the development of the midurethral sling as a treatment for stress urinary incontinence. Goldman is a professor of urology and vice chair of the Glickman Urologic Institute at Cleveland Clinic.
The first slings were reported probably in the early 20th century. Initially physicians used fascia from the patient's own body, but that required a bit of a surgery—a dissection taking a nice piece of fascia out and putting it under the bladder neck and proximal urethra. In order to avoid the morbidity of fascial harvest many people tried different synthetic materials. There were often a lot of problems; they didn't integrate in the tissues that well, and not all of them worked that well. In the mid-1980s to early 1990s, 2 professors in Scandinavia—Dr. Ulmsten and Dr. Petros—came up with a different theory of how stress incontinence in women developed and a slightly different way of using slings to treat them. The big innovation was they moved the sling from the bladder neck area to the mid to distal urethra. They tried a lot of different materials, and they finally found that a woven polypropylene mesh that had large pores actually worked quite well and was well integrated into the body. Essentially, after trial and error with animals and eventually humans, they came up with what became known as the midurethral sling. The first one was called a TVT—a transvaginal tape. The idea was that this would be a procedure that could be done with minimal anesthesia—just some sedation and local. It was introduced in the mid-1990s.
Well, [it is] the fact that you no longer have to do a big dissection to harvest the patient's own tissue. People generally use some sort of fascia from the patient, and they would take it either from the leg—from the fascia lata—or they would make a prepubic or suprapubic incision to harvest a nice piece of fascia from the lower abdominal wall. While that works very well and we still do that, it does increase, to some degree, the patient morbidity. There are physicians who aren't as comfortable doing that, and there are some patients who don't want to have a big surgery. Clearly, that surgery cannot be done under sedation in most cases. So, introducing something that with a prefashioned sling, [something] we're able to utilize with the patient in an ideal situation just under some deep sedation and local, really opened this up the ability for many more women to be treated and allowed many more physicians to be trained and to utilize this technology.
Now, it is a little bit of a double-edged sword because there has been controversy in the last decade over the use of mesh. Much of the controversy applied more to large prolapse meshes, but there clearly were some concerns with the midurethral sling. There have [even] been lawsuits. Some of this was based around [how] some people who started doing this had not been adequately trained. It was almost too easy to do, so they would do it, but I would suggest that there are nuances that really allow one who's well trained to do a much better job. As with anything, there are potential complications. There have been some studies that look at potential complications between midurethral slings and fascial slings, and in the big picture, they're very similar. Their may be different types of complications, but the overall rates are similar. Again, as with anything, if you do enough of these, there can be some major complications. But I will [say] that the FDA reviewed the data and essentially came out years ago suggesting that [for] the midurethral sling, as well as the transobturator version of the sling, there's good data. Some of the other types of mesh products [were ones where they] issued some concerns, but for these 2 types of midurethral slings they reviewed the data years ago and were fine with [them].
I will also [say] that most of the organizations that are involved in this area, from the [American Urological Association (AUA)] to the [American College of Obstetricians and Gynecologists (ACOG)], [the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU)], [the American Urogynecologic Society (AUGS)], and a lot of other organizations, have joined in on a position paper that goes over a lot of the details of the midurethral sling, and supports it. The most recent iteration of this was just published about 2 months ago. It was primarily sponsored by SUFU and by AUGS, it's available online on a lot of the different websites, and it was supported by many of these other organizations.There are different versions. There is a version that is almost a physician statement [that] goes over what everyone thinks about this midurethral sling, and there's also FAQs for physicians as well as FAQs for patients. I keep them printed [out] and give these FAQs to my patients because it really goes over everything—what is it made of? How is it done? What are the outcomes? What are the potential risks? What are the facts about lawsuits?—to make them understand that. So, it's a very helpful item.
There were 2 common treatments that were typically used prior to the midurethral sling. One was a retropubic bladder neck suspension, or otherwise called a 'Burch suspension,' which entails going into the abdomen. It used to be an open abdominal procedure, so it had [a lot] more morbidity. Now, a lot of people might do it laparoscopically or robotically. It's a good operation for appropriate patients. The other operation was the autologous fascial sling, which again, is a good operation for many patients, but all of these are more invasive. By introducing something that was what I would call, 'less invasive, more reproducible,' really opened treatment to many more patients. Now, again, as we touched upon, there has been some concern with mesh and there are some practitioners who have gone back to using Burches or facial slings for more of their patients. We still do use those procedures in select patients, or perhaps for a patient who had a prior midurethral sling and had a complication or something of that nature. But I think in the big picture, by introducing something that was much more step by step—you do A, you do B, you do C—made it much more straightforward and opened it up to many more patients to be successfully treated. As I mentioned, in certain respects, that's a double-edged sword because it may have opened it up to some surgeons who may not have been ideal for doing this procedure. But [overall], it's been a very positive thing, and it's really opened the door to [treat] many more patien