EAU 2024 Annual Congress round-up

Oral vaccine for UTIs is potential alternative to antibiotics, finds long-term study

Recurrent urinary tract infections (UTIs) can be prevented for up to nine years in more than half of people given an oral spray-based vaccine and is a potential alternative to antibiotic treatments, finds research.

Initial results from the first long-term follow-up study of the safety and effectiveness of the MV140 vaccine for recurrent UTIs were presented at the 2024 European Association of Urology (EAU) Annual Congress in Paris, France. They show that in both men and women with recurrent UTIs, 54 per cent of study participants remained UTI-free for nine years after the vaccine, with no notable side-effects reported. Full results of the study are expected to be published by the end of 2024.

UTIs are the most common bacterial infection. They are experienced by half of all women and one-in-five men and can be painful and uncomfortable. Recurrent infections, needing short-term antibiotic treatment, develop in between 20-to-30 per cent of cases. With antibiotic-resistant UTIs now on the rise and drugs becoming less effective, new ways of preventing and treating these infections are needed.

Carried out by clinicians at the UK’s Royal Berkshire Hospital, this long-term follow-up study looked at the safety and efficacy of the MV140 vaccine in 89 patients originally treated privately at The Urology Partnership Reading. MV140 is a new vaccine for recurrent UTIs and is administered with two sprays of a pineapple-flavoured suspension under the tongue every day for three months. While researchers have previously studied MV140’s short-term safety and effectiveness, this is the first long-term follow-up study to report globally.

Participants in the trial were all aged over 18 years and were UTI-free when they were initially offered the vaccine. None of the participants had other urinary abnormalities such as catheters, tumours, or stones.

The average infection-free period across the cohort was 54.7 months (four and a half years) – 56.7 months for women and 44.3 months, one year less, for men. Around 40 per cent of participants reported having repeat doses of the vaccine after one or two years

Dr Bob Yang, Consultant Urologist at the Royal Berkshire NHS Foundation Trust, UK, who co-led the research, said: “Before having the vaccine, all our participants suffered with recurrent UTIs, and for many women, these can be difficult to treat.

“Nine years after first receiving this new UTI vaccine, around half of participants remained infection-free. Overall, this vaccine is safe in the long-term and our participants reported having fewer UTIs that were less severe. Many of those who did get a UTI told us that simply drinking plenty of water was enough to treat it.”

He added that the vaccine is very easy to administer and could be given by GPs as a three-month course. “Many of our participants told us that having the vaccine restored their quality-of-life. While we’re yet to look at the effect of this vaccine in different patient groups, this follow-up data suggests it could be a game changer for UTI prevention if it’s offered widely, reducing the need for antibiotic treatments.”

Prof Gernot Bonkat, Professor of Urology at the Alta Uro Medical Centre for Urology in Switzerland, and the EAU Chairman of Guidelines on Urological Infections, said while the findings are promising, further research into more complex UTIs is needed, as well as research looking at different groups of patients, to better optimise how to use this vaccine.

“While we need to be pragmatic, this vaccine is a potential breakthrough in preventing UTIs and could offer a safe and effective alternative to conventional treatments.”

Developed by the Spain-based pharmaceutical company Immunotek, MV140 contains four bacterial species in a suspension with water. It is available off-license in 26 countries.

App-based therapy can help OAB, new data confirms

Combining pelvic floor exercises with behavioural therapy could be more effective than current approaches at helping men with frequent urges to urinate, new research in men has found.

The initial results from the Bladder Emptying Disorder Therapy (BEST) trial were presented at the 2024 European Association of Urology Annual Congress. They reveal that an app-based therapy leads to significant improvements in the lower urinary tract symptoms that many millions of men experience – hesitancy, straining, frequent urges to urinate, and emptying the bladder effectively. Full results of the trial are expected to be published later this year.

Carried out in Germany, this is the world’s first randomised controlled trial to look at combining pelvic floor training, behavioural therapy, and bladder control techniques for mild, moderate, and severe bladder emptying disorders in men, all delivered as an app-based therapeutic.

Bladder emptying disorders can start to appear from the age of 30 and typically affect a large proportion of men aged over 50. While clinical guidelines recommend physiotherapy, behavioural therapy, and lifestyle changes as a first-line of treatment, they are often neglected by clinicians due to a lack of available evidence.

Prof Christian Gratzke, from University Hospital Freiburg in Germany, who co-led the trial, commented: “Frequent urges to urinate and issues emptying the bladder are the most prevalent urinary conditions we see in men after urinary tract infections.”

Up until now there’s been little data available to back physiotherapy, he noted. “We’re confident that we now have that data, and making this form of therapy available digitally could be a game changer for the millions of men who struggle day-to-day with issues emptying their bladder.”

For the 12-week study, researchers recruited 237 men aged over 18 years from across Germany. Half the men were randomised to receive standard medical care, while the other half were given access to the Kranus Lutera app-based therapy alongside standard care. The participants were asked to record a urination diary, which was used to inform their treatment, and complete questionnaires about the severity of their symptoms and their overall quality-of-life.

After 12 weeks, the trial found significant and clinically meaningful improvements in symptoms and quality-of-life measures from participants given the app-based therapy, who reported an average seven-point increase in symptom scores compared to those in the control group. The study found that the app-based therapy was more effective than medical therapy.

“For those with mild-to-moderate urinary symptoms, this digital therapy is without side-effects and improves symptoms by a magnitude we have not seen before. Simply strengthening the pelvic floor makes all the difference, it’s a no brainer,” said Prof Gratzke.

Five-year interval is safe for prostate cancer screening, research shows

A prostate-specific antigen (PSA) blood test every five years is sufficient to screen low-risk men for prostate cancer, new research has shown.

In Europe, only Lithuania routinely screens men for prostate cancer based on their PSA levels, as the test has historically been seen as insufficiently reliable.

The German study, presented at the 2024 European Association of Urology (EAU) Annual Congress involved over 12,500 men aged between 45 and 50 years taking part in the ongoing PROBASE trial, which is testing different prostate cancer screening protocols. The research has also been accepted for publication in European Urology.

PROBASE is recruiting men aged 45 who are split into three groups based on their initial PSA test. Men with a PSA level of under 1.5 nanograms per millilitre (ng/ml) are deemed low risk and followed up with a second test after five years.

Men with a PSA level between 1.5-3ng/ml are deemed intermediate risk and followed up in two years. Those with a PSA level over 3ng/ml are seen as high risk and given an MRI scan and biopsy.

Of over 20,000 men recruited to the trial and deemed low risk, 12,517 have now had their second PSA test at age 50. The researchers found that only 1.2 per cent of these (146 in total) had high levels of PSA (over 3ng/ml) and were referred for an MRI and biopsy. Only 16 of these men were subsequently found to have cancer – just 0.13 per cent of the total cohort.

The EAU recommends that men should be offered a risk-adapted strategy (based on initial PSA level), with follow-up intervals of two years for those initially at risk, in which they include men with PSA over 1ng/ml. The new findings suggest that the screening interval for those at low risk could be much longer with minimal additional risk.

Lead researcher, Prof Peter Albers, from the Department of Urology at Heinrich-Heine University Düsseldorf, Germany, explained: “By raising the bar for low risk from 1-to-1.5ng/ml, we enabled 20 per cent more men within our cohort to have a longer gap between tests and very few contracted cancer in that time.

With nearly 14 million men aged between 45 and 50 in Europe, the numbers affected by such a change would be significant. Our study is still underway and we may find that an even longer screening interval of seven, eight, or even 10 years, is possible without additional risk.”

Current guidelines and policies from European governments and health bodies remain contradictory and unclear, leading to high levels of opportunistic testing and inequality of access to early diagnosis, according to further research presented at the EAU Congress.

The study reviewed early detection policies across the European Union and carried out focus groups with urologists to identify how guidelines were interpreted in clinical practice. Dr Katharina Beyer, from the Department of Urology at the Erasmus MC Cancer Institute in Rotterdam, Netherlands, carried out the research.

She said: “Some country’s guidelines are actively against screening, others are non-committal and a few, such as Lithuania, have some form of screening. But in many countries, if you ask for a test, you can get one, sometimes free and sometimes not. This means that well-educated men, who know about PSA tests, are more likely to be screened and get an early diagnosis, while others with less knowledge are at a disadvantage.”

Bladder cancer treatment can be better targeted and more effective, trials show

Testing for tumour DNA in the blood can successfully identify advanced bladder cancer patients who will not relapse following surgery, new phase 3 research presented at the 2024 European Association of Urology (EAU) Annual Congress showed.

This could allow doctors to target treatments more effectively to those who need it and spare those patients for whom further treatment is unnecessary, researchers say.

The findings from the screening phase of the IMvigor011 phase 3 trial show that just over 90 per cent of muscle invasive bladder cancer (MIBC) patients with a negative circulating DNA (ctDNA) test following surgery, which remained negative on follow-up, did not relapse. The findings mean that use of a ctDNA test could allow some patients to be spared further treatment with minimal risk.

Around half of MIBC patients experience cancer recurrence, often in the lungs and usually within two-to-three years. All patients are currently offered follow-up treatment such as chemotherapy or immunotherapy to prevent recurrence, for which the side-effects can be serious and life-changing.

Other phase 3 trial results, also presented at the EAU Congress, show that patients given immunotherapy, nivolumab, as a follow-up to surgery have an average survival of nearly six years, compared to four years for patients on placebo.

Prof Joost Boormans, Professor of Urology at Erasmus University Medical Centre in Rotterdam, Netherlands, and member of the EAU Scientific Congress Office, said: “Although we already knew that nivolumab improved disease-free survival in MIBC patients who received radical surgery, overall survival is what really matters following local treatment, such as radical surgery.

“These interim findings, which show that overall survival also improves, are very encouraging, particularly as this hasn’t been the case in other recent immunotherapy trials.

“The question for regulators and healthcare authorities is whether the improvement in overall survival is enough to justify licensing or prescribing the drug for all patients, in the knowledge that some of these patients would have been cured of their cancer by surgery alone.

“This is where the findings from the IMvigor011 trial could really make a difference, by allowing us to select patients at highest risk who will benefit the most from treatment while sparing others for whom it isn’t needed.”

Meanwhile, separate research presented at the EAU Congress showed how a simple urine test can more than halve the number of cystoscopies necessary to follow up high-risk bladder cancer patients.

Initial results from a two-year study suggest that there is also no increased risk of recurrence in patients who had a urine biomarker test rather than a standard flexible cystoscopy. Full results on this aspect of the trial are expected in the summer.

The study was carried out in Denmark, where post-surgical follow-up for high-risk bladder cancer recommends cystoscopies every four months for two years. The new research is the first time a urine biomarker test has been assessed in a randomised interventional controlled trial with high-risk patients.

This trial design allowed the researchers to assess whether the test could reduce the number of cystoscopies patients had to undergo, as well as picking up any signs of returning cancer. Previous studies have only assessed biomarker tests observationally, adding the biomarker tests to existing standard of care.