Andrew C. Peterson, MD, MPH, on the QOL impact of the artificial urinary sphincter

In this video, Andrew C. Peterson, MD, MPH, describes the background and notable findings from the study “The Artificial Urinary Sphincter Improves Depression, Anxiety and Overall Emotional Health in Men With Stress Urinary Incontinence; Analysis of the Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO),” which he presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting in Scottsdale, Arizona. Peterson is a professor of surgery at Duke University in Durham, North Carolina.

Transcription:

Please describe the background for this study.

The AUSCO study, or the Artificial Urinary Sphincter Clinical Outcomes trial, was a multi-institutional, multinational study that was actually sponsored by Boston Scientific to look at the effects of the artificial urinary sphincter, or the AUS, on both clinical outcomes, which involved primary outcome being the cure or improvement of incontinence in men undergoing treatment with the device, and also secondary outcomes such as quality of life issues, as outlined with various types of questionnaires.

It involved 18 sites overall. I'm very honored to be able to present components of the preliminary data, because the study is still being wrapped up in conjunction with the AUSCO research team. The 3 primary principal investigators [included me as well as] Dr Hadley Wood at Cleveland Clinic [and] Dr Melissa Kaufman at Vanderbilt. But all of the other principal investigators are also primary components to the research project.

It was really put in place because of the company's requirements from the FDA, with their idea of potentially modifying the device in the future and bringing out different new types of devices that would also treat men for stress urinary incontinence. It's a prospective cohort where we enrolled men who were leaking after either treatment with prostate surgery for prostate cancer or TURPs or outlet procedures for BPH and lower urinary tract symptoms. Men had to leak. Before we enrolled every man, we documented how many pads they used per day, as well as the weight of the pads. We placed the device, and then we followed those men prospectively over time as a cohort, so they served as their own controls, meaning their baseline was the pretreatment and then postoperative follow-ups. We went out to 1 year with this cohort, and we evaluated them again with number of pads per day, and then patient outcome questionnaires to see their overall improvement.

What were some of the notable findings? Were any of them surprising to you and your coauthors?

Anecdotally and clinically, many of us who treat men with post-prostate cancer treatment incontinence or incontinence primarily from other causes such as trauma or other types of surgeries, many of us have always talked about, these men, when we meet them, are pretty severely depressed and they're anxious. Many of them tell us stories about how they become homebound. They don't leave the house any longer because they have to wear diapers or multiple pads. They have a fear of travel because of significant fear of going through security at airports and getting wanded because they have a wet pad that gets seen on the X ray machine. And then many of them can't go out or go to other countries because they have fear of being able to obtain products to help keep them dry. So they, in a sense, become homebound. Spouses and partners have told us these types of stories as well. Again, when we place these devices, in the past, we've noticed, again, anecdotally, a significant improvement in this type of behavior where the spouse will come in or the partner and say, "Hey, he's a different person now. We go out all the time." And we also have all...had stories of men coming back and telling us that the [AUS] changed their life and really increased their attitude and their outlook on life. So we always thought there was a very, very large component of depression, anxiety, and even anger that accompanied decision regret, we would call it, with the idea that they got treated for prostate cancer and now they're leaking and their life is in shambles. So we decided to take a look at some of these components of the patient-reported outcomes that we accrued in this study. Many of those PROs included the I-QOL or Incontinence Quality of Life score, the IIQ-7, and the EQ-5D. All 3 of those questionnaires have components to them that include questions about anxiety and depression. We decided to take a look at how those components of these individual surveys changed from before treatment with the artificial urinary sphincter and after treatment with the artificial urinary sphincter.

We were really surprised that we found that the anxiety components in the depression questions in those 3 questionnaires really improved drastically when we compared them to pretreatment vs post treatment. In fact, 1 of the questions on the questionnaire for the I-QOL, is "I feel depressed because of my urinary incontinence." That significantly improved to "almost not at all," from "almost completely always" before surgery to after surgery. The IIQ-7 seven has a question that says, has urine leakage affected your emotional health? And again, that improved from "significant" to to "almost not at all" affecting their emotional health after surgery. And then the EQ-5D has a question about anxiety or depression that improved significantly. All of these went from very, very remarkable negative scores, meaning impact on quality life to very, very remarkably positive scores with very high statistical significance. We're talking P value is less than .0001, so unarguably a significant change in these types of components of quality of life for these men.

This transcript was AI generated and edited by human editors for clarity.