By The Biomedical Observer
Let's get something out of the way: this article is about erectile dysfunction, penile implants, and sex. If you're uncomfortable with these topics, I completely understand. But if millions of men are dealing with this issue and it's affecting their quality of life, relationships, and mental health, then maybe - just maybe - we should be talking about it more openly.
Enter the IT MATTERS registry (NCT04200937), a study with possibly the most perfectly named acronym in clinical research history. It stands for... well, I'm not actually sure they've spelled it out anywhere, but the message is clear: erectile restoration matters. And it's time we treated it that way.
The Elephant in the Bedroom
Erectile dysfunction (ED) affects approximately 30 million men in the United States alone. By age 40, about 40% of men experience some degree of ED. By age 70, that number jumps to nearly 70%. And here's the kicker: most men don't talk about it. Not to their friends, not to their partners, and often not even to their doctors.
There's a reason pharmaceutical companies have spent billions marketing little blue pills - ED is incredibly common, and the demand for solutions is enormous. But here's what the commercials don't tell you: for many men, pills don't work. Neither do injections, vacuum pumps, or any of the other non-surgical options.
For these men, there's one treatment left: a penile prosthesis.
What Exactly Is a Penile Prosthesis?
A penile prosthesis (or penile implant) is exactly what it sounds like - a surgically implanted device that allows a man to achieve an erection. There are three main types:
1. Malleable (Semi-Rigid) Implants
These consist of bendable rods implanted in the penis. You literally bend it up when you want to use it and bend it down when you don't. Simple, reliable, and low-maintenance - like the Honda Civic of penile implants.
2. Two-Piece Inflatable Implants
These include cylinders in the penis connected to a pump in the scrotum. Squeeze the pump, fluid moves into the cylinders, and you're in business. Less natural-feeling than three-piece systems but fewer components to potentially fail.
3. Three-Piece Inflatable Implants
The Cadillac (or Tesla, if you prefer) of penile prostheses. Cylinders in the penis, a pump in the scrotum, and a fluid reservoir hidden in the abdomen. When you want an erection, you squeeze the pump, fluid flows from the reservoir into the cylinders, and the result is remarkably natural-looking and feeling. Press a release valve, and the fluid returns to the reservoir.
All three types are completely concealed within the body. Nobody knows you have an implant unless you tell them.
The IT MATTERS Registry: Finally, Real-World Data
The IT MATTERS registry is a prospective, multicenter study sponsored by Boston Scientific (one of the major manufacturers of penile prostheses) to collect long-term, real-world data on erectile restoration outcomes.
Here's what makes this study valuable:
Who's Being Studied
- Adult males (18+) with chronic, organic erectile dysfunction
- Patients who are candidates for penile prosthesis implantation
- Both first-time implants and revisions
What's Being Measured
- Erectile function using the International Index of Erectile Function (IIEF-EF domain)
- Depression symptoms using the PHQ-9 questionnaire
- Overall sexual function
- Work productivity
- Quality of life
How Long
- Follow-up at 6 months, 12 months, and annually thereafter
The principal investigator is Dr. Aaron Lentz at Duke University, with multiple sites across the country participating.
Why This Registry Matters (Pun Intended)
Here's the problem with penile implant research historically: most studies have been small, single-center, and short-term. We know that implants have high satisfaction rates in the short term, but what about five years out? Ten years? What happens when devices fail? How do outcomes compare across different patient populations?
These are the questions that a large, prospective registry can answer.
What We Already Know About Satisfaction
The existing research on penile implant satisfaction is actually quite encouraging. A 2025 study published in the Journal of Clinical Medicine found that 96% of patients reported that their prosthesis met their expectations, with subjective satisfaction rated at 8.7 out of 10.
Partner satisfaction is also high - studies consistently report rates around 82%. This matters because sexual function is inherently a couples' issue. If the implant works mechanically but the partner isn't satisfied, the procedure hasn't fully succeeded.
A narrative review in the International Journal of Impotence Research outlined strategies for improving functional outcomes after implant surgery, noting that patient education and expectation management are key factors in satisfaction.
The Mental Health Connection
Here's something that doesn't get discussed enough: ED and depression often go hand in hand. Men with ED have significantly higher rates of depression and anxiety. Their self-esteem suffers. Their relationships suffer. And the stigma around discussing these issues means many suffer in silence.
The IT MATTERS registry specifically tracks depressive symptoms using the PHQ-9, recognizing that successful treatment of ED can have benefits far beyond the bedroom. When men regain sexual function, many experience improvements in mood, self-confidence, and relationship quality.
A 2025 study comparing outcomes in psychogenic versus organic ED patients found that penile prosthesis implantation improved quality of life across both groups - suggesting that even when there's a psychological component to ED, the restoration of function can break the cycle of dysfunction and depression.
Device Reliability and Longevity
Let's talk about the practical concerns. How long do these devices last? What goes wrong?
A 2025 systematic review in the International Journal of Impotence Research found that mechanical failure occurred in 7.14% of patients, with 11.9% eventually needing revision surgery for various reasons.
Those numbers might sound concerning, but context matters. Inflatable penile prostheses are sophisticated mechanical devices implanted in a challenging environment. The fact that 90%+ are still working well enough to avoid revision is actually impressive. And modern devices are significantly more reliable than those from even 10-15 years ago.
When devices do fail, replacement surgery is usually straightforward. It's not like you're back to square one - you're just getting an updated component.
The Elephant's Still Here: Why Don't More Men Get Implants?
If penile implants have such high satisfaction rates, why don't more men with ED opt for them?
Several factors:
- Lack of awareness: Many men don't know this option exists
- Stigma: Even mentioning ED is hard; discussing surgical solutions is harder
- Physician reluctance: Some doctors don't bring up implants or refer to urologists
- Insurance concerns: Coverage varies widely
- Fear of surgery: Any procedure down there sounds scary
The IT MATTERS registry is part of an effort to generate the kind of robust, long-term data that can help normalize this conversation. When physicians can point to registry data showing high satisfaction rates and durable outcomes, it becomes easier to discuss implants as a legitimate, effective option.
Who Should Consider a Penile Implant?
Generally, implants are recommended for men who:
- Have tried and failed other ED treatments (pills, injections, vacuum devices)
- Have organic (physical) causes of ED that won't respond to conservative treatment
- Are in good enough health to undergo surgery
- Have realistic expectations about the outcome
They're not for everyone. Men with primarily psychological ED might be better served by therapy and medication. Those with active infections or uncontrolled diabetes may need to address those issues first.
But for the right patient, the transformation can be life-changing.
The Bigger Picture
ED is a quality-of-life issue. Full stop. It affects physical intimacy, romantic relationships, self-image, and mental health. Yet it's been treated as something embarrassing, something men should just deal with quietly, something not worthy of serious medical attention.
Studies like IT MATTERS push back against that narrative. They say: this is a real medical condition, these are real treatments, and we're going to collect real data to help patients and physicians make informed decisions.
If you or someone you know is struggling with ED that hasn't responded to other treatments, a conversation with a urologist about penile prostheses might be worth having. The data suggests that most men who take this step are glad they did.
And that, ultimately, is what matters.
Disclaimer: This blog post is for informational purposes only and does not constitute medical advice. Erectile dysfunction can have multiple causes and treatment decisions should be made in consultation with qualified urologists who can evaluate individual circumstances. Clinical trials and registries have specific eligibility criteria. Images and graphics are for illustrative purposes only and do not depict actual medical devices, procedures, mechanisms, or research findings from the referenced studies.
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