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Sexual QOL improved at 12 months following AUS placement

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"I think this is a very important trial, just to bring some importance about patients' worries about being sexually active with urinary incontinence," says LeRoy Jones, MD.

In this interview, LeRoy Jones, MD, discusses the study “Changes in Sexual Quality of Life in Patients With Stress Urinary Incontinence Treated With an Artificial Urinary Sphincter; Analysis of the Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO),”1 which he presented at the 25th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America. Jones is a urologist with Urology Austin in Austin, Texas.

Please provide an overview of this study and its notable findings.

LeRoy Jones, MD

LeRoy Jones, MD

The study that we're discussing is looking at the changes in the sexual quality of life in patients with stress urinary incontinence treated with the artificial urinary sphincter or AUS. This is the AUSCO trial, which stands for Artificial Urinary Sphincter Clinical Outcomes Trial. The reason that the study was done was to assess patient outcomes with the AUS, but then also facilitate future innovation regarding the AUS. This was a single-arm, prospective study. There were 17 sites. Basically, the patients underwent surgical implantation of the AUS at each site per their standard protocol, and then, typically 5 weeks or so after the device was placed, it was activated. The patients were their own controls. Questionnaires were given to patients before they were treated and then throughout the study. But we're focusing more on the data at 12 months. The primary end point was looking at pad weight reduction. The patients came in with a certain amount of leakage in a 24-hour period, and then at 12 months. We wanted to see the reduction in the pad weight tests. There were some secondary end points, basically focusing on quality of life. I was interested in the sexual quality of life, but there are other indices that were evaluated, such as depression and overall well-being.

What were some of the noteworthy findings, and were any of them surprising to you and your co-authors?

Being in practice for a number of years and speaking with patients, postprostatectomy incontinence is a pretty significant mental burden on patients. It's very debilitating, and it really just affects your overall quality of life. If the patient suffers from both erectile dysfunction and urinary incontinence, urinary incontinence is always the bigger problem. In my experience, treating these patients, these are really some of the happiest patients that you will have. There are a lot of key thought leaders [involved with this study]. Andrew C. Peterson [, MD, MPH], from Duke was looking at depression indices and how there was an improvement in depression. I wasn't really surprised by the findings regarding sexual activity or worrisome about being intimate, because many patients just want to treat their leakage. They may not be interested in treating the sexual dysfunction. But then, once the urinary issue has been addressed, now they're interested, because their confidence level has gone up. The specific item on the Incontinence Quality of Life questionnaire was item 22. The patient would answer if they're extremely worried or not at all. And then there are several answers in between that. The question is, "I worry about sex because of my urinary problems and incontinence." It's a pretty simple question. What we found at 12 months is that we had 98 patients respond. There are 115 patients in the study, so of the 98 patients who responded at 12 months, 43.9% were extremely worried prior to having their incontinence treated. After the incontinence was treated, that number dropped to 13.3%, so it was certainly a big change. It was statistically significant. In the patients who were not at all worried, it was 17.7% and then once the device was activated and 12 months later, those who were not worried at all was 37.8%. Again, those that have been in practice for a while will have an opinion that this is what they've seen, essentially, in taking care of patients, but it's nice to have a study to really verify [this] because there are no other studies that have been done that really looked at this question. If you're counseling a patient and they have both erectile dysfunction and urinary incontinence, you can say, "We do have information that shows that treatment of the incontinence will lessen your worry about sexual activity, and so that should probably be the first treatment, and then we can move on to treat the erectile dysfunction."

The finding that the improvement in sexual quality of life and that it was independent of age, BMI and diabetes was noteworthy. Could you talk about the implications of this for patient selection and treatment planning?

These are just general patients who came in. All the patients who had surgery were first-time patients. They weren't revision patients. Our average BMI for patients was 30.8. BMI basically didn't influence the results of the study. The average age of the patient was 69.9 years. Most of these patients had had radical prostatectomies. [Approximately] 21% of patients [had had radical prostatectomy and radiation therapy]. Diabetes didn't play a role. If the patient is a good candidate for an artificial urinary sphincter, there wasn't really anything that would prevent them from participating in the study. It's interesting. The AUS has been out for 51 years, and I'm not sure why we haven't done a trial like this previously, but again, I think this is a very important trial, just to bring some importance about patients' worries about being sexually active with urinary incontinence.

What are the potential implications for counseling patients considering AUS treatment regarding the potential benefits on sexual quality of life?

I think that when we counsel patients, we will bring our own experience with this type of surgery. In this particular study, there was a higher number of patients than expected who reported no erectile dysfunction. I think in in the real world—and this was bought up at the recent presentation of the study—most patients with urinary incontinence are also going to have erectile dysfunction. The 2 go hand in hand. There was a time when we were treating both at the same time, meaning putting in an AUS and then putting in a penile prosthesis in the same operation. But there have been some insurance coverage [issues] of this combined procedure, specifically with Medicare, and so the procedures need to be staged.

I think it's important for us as urologists to assess the degree of urinary incontinence that the patient has, and if they have any type of significant incontinence, I think it's really important for us to stress that we should probably treat the urinary incontinence before moving on to treatment of erectile dysfunction. I think this will help guide those who perhaps do less of these surgeries as to the order of treatment: deal with the urinary incontinence, get the patient sorted out, make sure the patient is happy, that there's no issues, and then move on to the penile prosthesis.

AUS surgery has really evolved. Like I said, it's been around for 51 years. There have been some modifications, and there are some future planned modifications, but this is a less-than-an-hour outpatient operation, so the patient satisfaction is very high. Most of these patients would repeat the procedure again, because overall, their experience with it is very positive. I've had patients [in whom] the incontinence was so mentally debilitating to them that they would tell me after the fact that they had thought about committing suicide. The average age of our patient is 69, 70, so these are guys who've generally had an overall pretty good quality of life. Patients will tell me, with the urinary incontinence, they're afraid to go out. They're afraid to interact. They'll tell me that they feel like a prisoner in their own home, because every time they leave, it's a big event, and they have to watch where you sit, what they sit on, what color pants they wear. There's a lot of internal anguish and stress that the patients go through. Obviously, I'm focusing more on the sexual issues, but again, the overall quality of life is really very important. The impetus is on us as urologists to ask patients about the incontinence. There are other minimally invasive procedures for patients with mild incontinence as well. That's probably the next arm of the study.

What future research directions do you envision to further elucidate the relationship between AUS and sexual QOL?

We're still analyzing our data from the study, looking at the quality of life. As far as sexual activity, there's nothing else within this study, because this study has already been done. I think the next go-round is maybe diving into the degree of sexual dysfunction that the patients have, and then, looking at after treatment, how the patients feel about it. I think that that's where we can probably improve because, again, we didn't really dive into it very deeply. We asked if the patient had erectile dysfunction. It was a yes or no; we didn't do a specific questionnaire about the degree of erectile dysfunction. We were interested if they were worried about being sexually active, and it turns out that they are. I think that this could be the springboard for more in-depth studies just to get more information. But the bottom line is that we should treat their urinary incontinence, and this is going to lessen the worry about being sexually active. That's really the big take-home message from the study. I think this opens the door to other studies addressing similar concerns.

REFERENCE

1. Jones L, Terlecki R, Peterson A, et al. Changes in sexual quality of life in patients with stress urinary incontinence treated with an artificial urinary sphincter; analysis of the Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO). J Sex Med. 2024;21(suppl_7):qdae167.137. doi:10.1093/jsxmed/qdae167.137

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