Prostate Surgery – Better Erectile Function and Urinary Control After Prostate Cancer Treatment

The Hidden Cost of Prostate Cancer Surgery

Prostate cancer is one of the most common cancers in men. The good news is that when caught early, it is often curable. The standard treatment for localized prostate cancer is surgery to remove the prostate gland. For many men, this surgery saves their lives.

Two common side effects of prostate surgery change lives in ways that doctors do not always talk about enough. The first is erectile dysfunction. The second is urinary incontinence. Not being able to hold urine. Leaking when you cough, laugh, or lift something heavy. These problems happen because of anatomy. The nerves that control erections and the muscles that control the bladder sit right next to the prostate. They are tiny. They are fragile. They are easy to damage during surgery. Even with robotic surgery, which is more precise than traditional open surgery, these complications are common. Up to 80 percent of men experience some degree of erectile dysfunction after prostate removal. Many struggle with urinary control for months or years.

• Erectile dysfunction affects up to 80 percent of men after standard prostate surgery.
• Urinary incontinence affects a significant minority, impacting quality of life.
• These complications occur even with robotic surgery, which is more precise than open surgery.

Surgeons have a technique to try to prevent this damage. It is called nerve sparing. The surgeon carefully peels the prostate away from the surrounding nerves, trying to leave them intact. This sounds simple. But there is a major problem.

How does the surgeon know that he is not leaving cancer cells behind on those nerves? The traditional approach relies on pre operative MRI scans and the surgeon’s experience. But MRI cannot see microscopic cancer spread. And even the best surgeon cannot be sure. This uncertainty leads to a difficult choice. Preserve the nerves and risk leaving cancer. Or remove the nerves and guarantee erectile dysfunction. A new technique called NeuroSAFE helps solve this problem. In the NeuroSAFE PROOF randomized phase 3 trial published in The Lancet Oncology, surgeons used intraoperative frozen-section analysis during robot-assisted radical prostatectomy to check the tissue margin next to the nerves while the operation was still in progress. Men treated with NeuroSAFE-guided surgery had better erectile function scores at 12 months than men who had standard robotic prostatectomy, while early cancer-control outcomes were not worsened. In plain English, NeuroSAFE gives the surgeon more real-time information: when the margin looks clear, the nerves can be spared more confidently; when cancer is seen at the edge, more tissue can be removed immediately.

What Is NeuroSAFE and How Does It Work?

NeuroSAFE was developed at the Martini Klinik in Hamburg, Germany. The name stands for Neurovascular bundle evaluation by Safe Frozen section Examination.

During the operation, the surgeon removes the prostate. But instead of ending the surgery, the prostate is rushed to the pathology lab. A pathologist freezes the tissue, cuts it into thin sections, and examines it under a microscope. They look specifically at the edges where the prostate was attached to the nerves. The whole process takes about 20 to 30 minutes. The pathologist calls the operating room with the results.

If the edges are clear of cancer, the surgeon knows it is safe to leave the nerves intact. The surgery ends normally. If cancer cells are touching the edge, the surgeon knows there is a risk. He can go back and remove additional tissue around the nerve on that side. This means sacrificing that nerve, but it ensures the cancer is fully removed. The patient is still under anesthesia. There is no second surgery. This real time information changes everything. Instead of guessing, the surgeon knows.

The NeuroSAFE PROOF trial was designed to test whether this technique actually improves outcomes for patients. Does better information during surgery lead to better erections and better bladder control after surgery?

Study Design and Participants

The NeuroSAFE PROOF trial was a phase III randomized controlled trial. This is the gold standard of medical evidence. Patients are randomly assigned to receive the new treatment or the standard treatment. Neither the patients nor the doctors assessing the outcomes know who got what.

The trial was conducted at five National Health Service hospitals in the United Kingdom. A total of 407 men with localized prostate cancer were recruited between January 2019 and December 2022. All men had good erectile function before surgery. Their IIEF-5 scores were at least 22 out of 25. They could get erections without medication. This was important because the study wanted to measure how well surgery preserved function, not how well pills restored it. The average age was about 58 years. Most men had clinically significant prostate cancer. About 75 percent had intermediate risk disease. The rest had high risk disease. This was not a study of men with very low risk, watch and wait cancer. These were men who truly needed treatment. The men were randomly assigned to one of two groups. One group received standard robot assisted radical prostatectomy. The surgeon used pre operative MRI and his clinical judgment to decide whether to spare nerves. This is the standard of care in most hospitals.

The other group received NeuroSAFE guided surgery. The surgeon started with a plan to spare nerves on both sides. Then the prostate was sent for frozen section analysis. If cancer was found at the margin, the surgeon went back and removed more tissue on that side, sacrificing the nerve.

Both groups of patients were followed for 12 months. They completed questionnaires about their erectile function and urinary control at 3, 6, and 12 months after surgery.

Key Results: What the Study Found

At 12 months after surgery, men in the NeuroSAFE group had significantly better erectile function. Their average IIEF-5 score was 12.7. The standard surgery group scored 9.7. The difference of 3.18 points was highly statistically significant. The p value was less than 0.0001, meaning the difference was extremely unlikely to be due to chance.

What does a 3 point difference mean in real life? The IIEF-5 scale ranges from 1 to 25. A score of 17 to 21 is mild dysfunction. A score of 22 to 25 is normal function. A difference of 3 points can move a man from severe to moderate dysfunction, or from moderate to mild. Many men in the NeuroSAFE group could achieve penetration. Fewer in the standard group could.

The difference in nerve sparing rates explains the result. In the NeuroSAFE group, 82 percent of men had bilateral nerve sparing, meaning nerves on both sides of the prostate were preserved. In the standard surgery group, only 56 percent had bilateral nerve sparing. That is a huge difference of 26 percentage points. NeuroSAFE allowed surgeons to safely preserve nerves that they would have removed otherwise.

Urinary continence also improved with NeuroSAFE, at least in the short term. At 3 months after surgery, men in the NeuroSAFE group had significantly better bladder control. Their ICIQ scores, which measure incontinence, were 5.8 compared to 7.4 in the standard group. A lower score means less leakage. By 6 months, the difference had disappeared. Both groups had similar continence. This suggests that NeuroSAFE helps men recover bladder control faster, but the final result at one year is the same.

Summary of NeuroSAFE PROOF Trial Results

The safety profile was excellent. Serious adverse events occurred in only 3 percent of patients in both groups. There were no deaths attributed to the study intervention. The extra time required for NeuroSAFE, about 40 minutes longer surgery, did not increase complication rates.

Who Benefits Most From NeuroSAFE?

Not every man with prostate cancer benefits equally from NeuroSAFE. The researchers looked at a specific subgroup of patients. Those who were not initially recommended for bilateral nerve sparing. Before surgery, a team of urologists and radiologists reviewed each patient’s MRI scans and biopsy results. They made a recommendation. Some men were told that bilateral nerve sparing looked safe. Others were told that the cancer was too close to the nerves on one or both sides. They were not good candidates for nerve sparing.

These men had the most to lose. Under standard surgery, they would likely have had one or both nerves removed. Their chance of recovering erectile function was very low. The results were striking. In this high risk subgroup, NeuroSAFE made an even bigger difference. The improvement in IIEF-5 score was 3.77 points greater than in the standard surgery group.

• Men not initially recommended for bilateral nerve sparing saw the greatest benefit.
• NeuroSAFE allowed surgeons to safely preserve nerves that would have been removed otherwise.
• This subgroup represents the patients with the most to gain from the technique.

What happened during surgery? The NeuroSAFE protocol started with an intention to spare nerves on both sides, regardless of the pre operative recommendation. Then the frozen section analysis told the surgeon whether this was safe. In many cases, the margins were clear. The surgeon could leave the nerves intact. The patient got bilateral nerve sparing even though his pre operative imaging suggested it was too risky.

This is the real power of NeuroSAFE. It provides information that imaging cannot. Microscopic cancer spread cannot be seen on MRI. But it can be seen on a frozen section. Surgeons no longer have to guess. They know.

Is There a Trade Off With Cancer Control?

Any technique that aims to preserve nerves must answer a critical question. Does it leave cancer behind? The researchers looked closely at this. They found a small increase in positive surgical margins in the NeuroSAFE group. Twenty one percent of NeuroSAFE patients had a positive margin compared to 13 percent in the standard group.

But the details matter. The increase was almost entirely in small, unifocal positive margins. These are the kind that most studies show do not increase the risk of cancer recurrence. Large or multifocal positive margins, which are more concerning, occurred at the same rate in both groups, about 14 to 16 percent. The researchers had a specific protocol for when to perform a secondary resection. If the frozen section showed a large area of cancer, or high grade cancer, the surgeon went back and removed more tissue. If the frozen section showed only a tiny focus of low grade cancer, the surgeon left it. This explains why the small margin rate was higher in the NeuroSAFE group. The study chose to tolerate very small margins in exchange for preserving nerves.

What about actual cancer outcomes? At 12 months of follow up, there was a small difference. PSA persistence or biochemical recurrence occurred in 9 percent of the NeuroSAFE group versus 6 percent of the standard group. This is a difference, but the study was not designed to detect differences in cancer outcomes. The follow up was too short. The numbers were too small.

The researchers plan to follow these patients for 5 years. That will give a much clearer answer about whether the small increase in positive margins translates into any meaningful difference in cancer control. For now, the early data is reassuring. Long term retrospective studies of NeuroSAFE have shown no oncological disadvantage.

What This Means for Patients and Doctors at APUMN

If you or someone you love is facing prostate cancer surgery, and preserving erectile function is important to you, ask your surgeon about NeuroSAFE. Not every hospital offers this technique. It requires a pathologist who is trained in frozen section analysis of prostate tissue. It requires coordination between the operating room and the pathology lab. It adds about 30 to 40 minutes of anesthesia time. It costs more. But the evidence is now clear. A large, high quality randomized controlled trial has shown that NeuroSAFE improves erectile function and speeds up urinary control recovery. This is not experimental. This is proven.

When you meet with your surgeon, here are some questions to ask. How many NeuroSAFE procedures have you performed? What are your functional outcomes for patients who receive NeuroSAFE versus those who do not? Does your hospital have a pathologist available for frozen section analysis during surgery? If your surgeon does not offer NeuroSAFE, you might consider traveling to a center that does. For men with good pre operative erectile function, especially those with intermediate or high risk cancer who might otherwise be denied nerve sparing, the potential benefit is substantial.

At APUMN (Adult & Pediatric Urology Medical), we do not perform prostate surgery ourselves. We are urology specialists focused on men’s health, including erectile dysfunction treatment. But we work closely with cancer centers. When a patient comes to us with ED after prostate surgery, we help him recover function with pills, injections, shockwave therapy, or implants. And when a man is facing surgery, we counsel him on his options. We tell him about NeuroSAFE. We help him find a surgeon and a center that offers this technique.

The decision is personal. Every man must weigh the benefits of preserving erectile function against any potential risk to cancer control. But now, with the NeuroSAFE PROOF trial, that decision can be based on high quality evidence.

Summary and Key Takeaways

The NeuroSAFE PROOF trial is a landmark study. It is the first randomized controlled trial to show that a surgical technique can improve both erectile function and urinary continence after prostate cancer surgery. The evidence is strong. Four hundred seven patients. Twelve months of follow up. Statistically significant differences in the primary outcome. Consistent results across multiple sensitivity analyses.

• Erectile function outcomes were significantly better in the NeuroSAFE group at 12 months.
• Early urinary continence improved, though the benefit diminished by 6 months.
• Men with intermediate and high risk disease, who are often denied nerve sparing, may benefit the most.

What does this mean for you? If you are a man with localized prostate cancer and good erectile function before surgery, you should know about NeuroSAFE. You should ask your surgeon about it. You should consider traveling to a center that offers it if your local hospital does not. The technique is safe. The complication rate is no higher than standard surgery. The trade off with cancer control appears acceptable, though longer term follow up is needed.

• NeuroSAFE significantly improves erectile function and early urinary continence after prostate cancer surgery.
• The benefit is greatest for men who would not otherwise have undergone bilateral nerve sparing.
• The technique is safe, with no increase in serious complications.

Prostate cancer treatment has come a long way. We are better at curing the disease than ever before. But curing the cancer is not enough. Patients want to live well after treatment. They want to have sex with their partners. They want to go back to work without worrying about leaking urine. NeuroSAFE is a step toward making that possible.

The authors of the study concluded that guidelines should be updated to include NeuroSAFE as an adjunct to guide nerve sparing during robotic prostatectomy. That is a strong recommendation from a high impact journal. It is worth paying attention to.

If you are facing this decision, take your time. Gather information. Talk to your surgeon. Talk to other men who have been through it. And remember that preserving your quality of life is not selfish. It is part of good cancer care.

Medical Disclaimer

The information provided in this article is for educational purposes only and does not substitute professional medical advice. Always consult a licensed healthcare provider for diagnosis and treatment recommendations specific to your situation.

Author

John K. Matsuura, M.D.