Christopher Chermansky: Great. Thank you so much, Alan. Hello, everyone. Yeah, so in February at the SUFU 2026 winter meeting, the meeting ended on Saturday with a panel where I was asked to moderate a session on optimizing bulking agent therapy in women with stress urinary incontinence. And I did this panel with my panelists here, Sara Lenherr from the University of Utah and Annah Vollstedt, who is at the University of Iowa, both in their Department of Urologies.
So the focus of this whole panel was really on the most popular bulking agent used right now in functional urology here in the states, which is Bulkamid. So, Bulkamid is polyacrylamide hydrogel, which I'll abbreviate here as PAHG. And its composition is listed here is mostly water, 97.5%, but then you've got that 2.5% of cross-linked polyacrylamide. It's biocompatible, non-biodegradable, and it does not migrate, which is great. It's been in use in Europe for the last 20 years, since 2006. And the company at the time, Contura, obtained FDA approval here in the US about six years ago in 2020. And its mechanism of action, as with all bulking agents, is to provide urethral coaptation.
So we started our panel putting forth this poll to the audience. And we had, as you can see, there are 46 participants that answered, asking them where they do currently their injections of Bulkamid, either in the OR or in the clinic, or both. And as you can see here, 50%, at least half did it really in the OR, or an ASC exclusively, and about 30% did it in the clinic as much as possible. And then you've got 15% preferring one versus the other.
And so as far as the first part of the presentation, we really focused on how my two panelists, Dr. Lenherr and Dr. Vollstedt, do most of their Bulkamid injections, which is actually in the office or the clinic. So listed here are the step-by-steps of what they do to be able to do that injection, starting with intraurethral lidocaine jelly, in combination with a periurethral block placed at 3:00 and 9:00, using 2% lidocaine and a 25-gauge needle, and the scope gets set up. And then you've got an assistant, an MA who regulates the inflow rate. At the beginning, the outflow's turned off, and obviously you place the specific scope that Bulkamid requires you to use for doing these injections. And as you're doing your cushions, if you will, and there are four of them that you place for a total volume of two milliliters, you're looking for that visual coaptation. And in the office with the patient awake, you could certainly have them do a dynamic cough stress test as needed to confirm that you've got a good coaptation there.
So, the next scenario involved asking the audience, "Typically how much will you do after or beyond the first injection?" So, patient was presented who initially received her two cc's of Bulkamid and she was 85% dry for about two weeks, and then it recurred, her SUI, and she was then only about 20% better. So, we talked about the package instructions talking about specifically the max volume being two cc's per treatment session. And basically, in there it states that you can actually repeat this up to a total of three times, and this is done typically a month apart or four weeks, and your total cumulative volume should really be no more than six cc's. And making the point, obviously if you go beyond that, that you run the risk of over-correcting and that can lead potentially to urethral obstruction.
So in the package insert again, which summarized the FDA qualifying trial that Contura did comparing Bulkamid to Contigen, you can see the columns here for Bulkamid and Contigen, and you've got at least about a third in each arm going on to receive potentially a total of three separate sessions of the bulking agent, and the volumes are very different here. Right? So you're staying within that two cc's each time you're injecting with Bulkamid but as you can see here with Contigen, people were going up as much as five. And if you go all the way down to the bottom, the mean volume injected for all injections is a respectable 3.3 for the Bulkamid. And for Contigen, it was close to nine, with the max going even as high as 42, which seems awfully high.
So, but again, the next focus was then on retention and how to manage this. So, this was a poll question put forth to the audience. And as you can see here, if you've got a patient who initially has retention, about 65% will favor either clean intermittent cathing, or 63% will certainly consider a temporary Foley. Only about 18% favored urethral dilation.
So, that led us into the next case scenario, which is a 50-year-old female with SUI and ISD who received her initial two cc's of Bulkamid, she went into retention. As you can see, the PVR was 350. She was taught to straight cath. A week later, she was still straight cathing and still in retention, so urethral dilation in the clinic was performed. And a week after that, still in retention and a uroflow was performed. I don't have the tracing, but you can see the parameters there. She only voided 150. Her Qmax was 4.4, which is low. Voiding time was prolonged at 60, the pattern was flat, and her PVR was 450.
So the panelist at the time, I believe it was Dr. Lenherr, discussed taking the patient to the OR and doing an incision of one of the cushions. And that was successful, in that a 14 Foley was left overnight, and two months post-op she had no recurrent stress incontinence and her PVR was minimal.
And as far as moving on to the next topic of discussion, which is the use of Bulkamid after a failed sling, we summarized these four studies over the last 10 plus years. The most recent two studies here on the left were systematic reviews and meta-analysis, where again, you've got pretty high patient satisfaction rates, 77%, 80% were either cured or greatly improved after their Bulkamid. And then the earlier studies again showed significant improvement as well in these patients who received bulking after a failed sling, which is obviously great, because when you're dealing with a patient like this, if their hyper mobility has been adequately focused and treated, then you're really isolating that SUI patient is having true ISD. And that's where this treatment really comes in to full view and is very successful, any bulking agent after a sling, really.
So the technique after a sling was discussed and reviewed. As you can see here on the left, you've got two cystoscopic appearances, one of the urethra open and the other of the urethra closed after injecting the Bulkamid injections. And typically this is done, if you can, just right above where the sling can be suspected, if you will, on cystoscopy. So in this particular study from almost 10 years ago in Neurourology and Urodynamics, you've got a median volume at 6:00 was one cc, and then you've got your 3:00 and 9:00 positions with 0.5 cc's and this seemed to work quite well in this series.
So then the panel moved on to a discussion of how to deal with the patient who comes in with severe mixed urinary incontinence. So both urge incontinence and stress incontinence thought due to ISD. And the scenario here was an 80-year-old female with urine leakage all the time. On exam, even with positioning, she has obvious gross leakage. She voids small amounts and she has continued incontinence between her voids. As you can see, she's very incontinent here, using up to six briefs per day, which are soaked. She's failed initial conservative medical therapy for OAB. So, we discussed addressing both types of incontinence at the same time, using a combination of Bulkamid and Botox at that same time.
And interestingly, at the SUFU winter meeting back in February, there were two abstracts here presented as non-moderated posters, one out of Houston at the University of Houston, and the other was at the City of Hope there in Southern California. And we'll start with the Houston abstract. Again, 25 patients receiving Bulkamid and 100 units of Botox at the same time. The retention rate was quite low here, only 4%. And as far as measuring PVRs in these patients, not too much of a change, from 15 up to 66 on average. And 60% achieving really good resolution of their mixed urinary incontinence symptoms three to five weeks post-treatment.
And then below a series of 60 patients, again, the average injection volumes ranging from 1.2 to two. And again, all these patients received 100 units of Botox. And in this series, they actually quoted about 28% that developed transient postop retention, and they did see an association with this happening in those who had a little bit of a higher baseline PVR, which is not too surprising. And of course, they brought forth the need perhaps and if you're going to do this to get pre-op bladder function assessment, which I wholeheartedly agree with if you're undertaking looking at doing this type of combination therapy.
So in conclusion, we covered during this panel, nuanced bulking practices that have been developed by various surgeons in our subspecialty that are used to treat female stress incontinence. We certainly concluded that there were many clinical scenarios beyond the index patient that was certainly evaluated for at the time of FDA approval for Bulkamid. And that today's, or not today's presentation, but the presentation then represented the starting point for a broader discussion on the use of bulking agents to treat female stress incontinence.
Alan Wein: So, do you think that bulking agents represent a reasonable initial choice for somebody that has, let's say even up to moderate stress incontinence? And does it interfere with the subsequent placement of a sling either retropubically or transobturator?
Christopher Chermansky: I think with what we have today with Bulkamid, I think we've had really, really great results. I've been doing bulking agent injections for 30 years, started in the '90s with collagen or Contigen, and moved on to Coaptite once that was no longer manufactured by Bard, at least what, 10 or 15 years ago. And then when Bulkamid was approved, many of us switched after seeing the results in Europe. And yes, I do think that this is an excellent option, especially for patients who are a little more risk averse maybe with getting a sling. I do think that the success of patients even with moderate stress incontinence is pretty good using this type of therapy.
And as far as whether it causes any issues going and following it with a sling, I don't think so. It's not been what I've seen. I don't see as much of that happening as I did with previous bulking agents where I've had to go on and do a sling after an initial bulking. But I mean, I don't see that being an issue if that's what's needed in order to further try to treat and improve that patient's stress incontinence.
Alan Wein: Last question. Are the patients who go into urinary retention more apt to be dry afterwards than the ones who don't?
Christopher Chermansky: Yeah, I mean, that is the thinking. I do think that that's not always such a bad thing if it's just a transient retention for a day or two. Right? And often you've got that factor, if you will, of the anesthetic drugs from the procedure if you're doing this in the OR or the ASC, that could potentially be playing a role. So no, I don't think that's such a bad thing at all, and that it does seem like those patients are often happy once their retention resolves.
Alan Wein: So listen, thanks so much for adding to our education about bulking agents. Really appreciate it.
Christopher Chermansky: Sure.Oh, absolutely. Thanks, Alan.
Alan Wein: Take care, my friend.