Typically, your treatment options for prostate cancer can depend on various factors. These include your tumor’s location and your overall health. For people who are in good health and whose tumor hasn’t moved from the prostate, their doctors may suggest a radical prostatectomy. In this procedure, a surgeon removes the prostate, surrounding tissue, and seminal vesicles. They may also remove nearby lymph nodes at the same time. While this is a life-saving procedure, it can come with certain side effects such as incontinence. That’s where a ProAct device can be helpful. What do you do, then, if the device that’s supposed to help improve your quality of life starts to fail?
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A radical prostatectomy can result in incontinence for multiple reasons associated with treatment. To put them into context, it’s important to know that continence, or your ability to hold in your urine, is usually managed by the combination of the detrusor muscle, the intrinsic sphincter, the rhabdosphincter, and the pubourethral ligaments. One sphincter is internal, and the other is external; both usually work together to hold your urine in until your body signals them to open, allowing you to urinate.
The internal sphincter, known as the proximal urethral sphincter, is usually removed during a radical prostatectomy. The procedure also removes the pubourethral suspensory ligaments. This means the remaining sphincter and muscle must manage continence.
Continence also relies on the proper functioning of the autonomic and voluntary nervous systems, as well as the urinary tract muscles. If any of these are damaged during the surgery, you may experience incontinence.
While incontinence can be a temporary issue after a radical prostatectomy, some men find it to be a permanent problem that needs to be addressed. According to this study, 67-92.4 percent of men who had an issue with incontinence after surgery and underwent assessment showed intrinsic sphincter deficiency (ISD). A smaller percentage (33.7-40 percent) could be attributed to detrusor overactivity (DO), in which the detrusor muscle contracts abnormally.
When first diagnosed with incontinence, your doctor may opt for conservative treatments such as being more physically active, monitoring your water intake, managing your weight, avoiding constipation, and avoiding smoking. Pelvic floor exercises and learning bladder control may also help. If none of those treatments work, they may prescribe medications such as anticholinergics, beta-3 agonists, and tricyclic antidepressants.
Depending on the type of incontinence you’re dealing with, medical devices are the next step if medications don’t work. That’s where devices like the adjustable continence therapy for men (ProACTTM) come in.
The ProACT device is usually recommended to treat stress incontinence. With stress incontinence, you can experience urine leakage when you cough, sneeze, or lift a heavy object. The condition gets its name from the stress or pressure that’s placed on your bladder.
ProACT was developed as an alternative treatment for male stress urinary incontinence and is considered to be an effective treatment according to the American Urological Association (AUA) guidelines and is also approved by the Food and Drug Administration (FDA). The ProAct device is an inflatable paraurethral balloon that passively compresses the urethra. Each balloon is attached to a reinjectable titanium port placed in the scrotum for future percutaneous adjustments of the balloon volume. Unlike some other devices, it offers the flexibility to adjust and personalize treatment. The procedure is also less invasive than other surgical options.
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Although the ProAct device is considered to be an effective treatment option, it’s worth noting that it can be less effective for people who underwent radiation therapy. Radiation makes your urethra stiffer, so the usual passive pressure from the ProAct device may not have the desired effect.
In addition, one study showed that the ProAct device may have certain functional issues or adverse effects. This study assessed 31 peer-reviewed publications on the device, yielding data from 1,607 patients treated with the ProAct device. Of that number, 752 adverse effects were recorded. The most common issues were mechanical failure (30 percent), device migration/malposition (21 percent), and device erosion (16 percent).
Researchers also collected data from the Manufacturer and User Facility Device Experience (MAUDE) database. According to MAUDE, the ProAct devices were removed from 24 percent of patients who had them implanted and revised or reimplanted in 28 percent of cases. In that database, the commonly identified adverse effects were device erosion at 49 percent, surgical site infection at 19 percent, and urinary retention at 11 percent.
Although those numbers may seem daunting, consider a study that included two centers in Madrid and Germany and examined the adverse effects of the Adjustable Transobturator Male System (ATOMS®) device. This is another treatment option for urinary incontinence. When placed in 187 patients who had persistent stress urinary incontinence after surgery, there were 51 complications after implantation. The most serious of these complications were primary wound infection at 4.3 percent and long-term cutaneous erosion with subsequent infection at 8.02 percent.
In one case, researchers documented the late erosion of an ATOMS device five years after implantation. That patient experienced a return of his incontinence when the device’s bulbar urethra eroded.
Finally, the artificial urinary sphincter (AUS) has the largest body of literature available for review, and its numbers are just as interesting. In a retrospective study of 168 patients with AUS placement, 37.5 percent of cases resulted in AUS failure requiring surgical revision. The main causes of these adverse effects were mechanical failure, urethral erosion, and infection. In another large retrospective multicenter study, researchers found a complication rate of 28 percent at 32 months’ follow-up after AUS placement.
Let your doctor know immediately if your ProAct device is no longer as effective as it once was. Depending on the issue, your doctor may repair or replace the device. Your doctor may also be able to replace separate parts of the device. For example, if the urethral balloon ruptures or develops a leak, your doctor can remove it and reimplant it. This procedure can be performed under general anesthesia or using a spinal block.
Of course, the exact way forward will depend on your doctor’s assessment of what may have gone wrong with your device. The important point is that you should tell your doctor at the slightest indication that your incontinence is returning. The assessment may include a physical exam and imaging tests to determine the device’s current condition.
The ProAct device has been helpful for many men with stress urinary incontinence that developed after a radical prostatectomy. While adverse effects can occur, they can also be remedied. The key is to talk to your doctor so they can determine the best way to help you.
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