A 72-Hour Update on the Aurie Reusable Catheter: New 578-Patient RCT Shows 29% UTI Rate with Reusables vs. 34% with Single-Use, Plus 35% Fewer Antibiotics
Published: May 22, 2026
By: Zeeshan Khan
Reading time: 16 minutes
Category: Medical Devices / Healthcare Economics / Public Health
Note: May 22, 2026 – This is an update to the previous article: FDA Authorizes First Reusable Catheter After 50 Years of Disposables – But Washer-Disinfector Cost Remains Unclear
SOUTHAMPTON, England / WASHINGTON, D.C. – May 22, 2026 – Three days after The 5 Ws reported on the FDA’s quiet authorization of the first reusable intermittent urinary catheter – and the significant unanswered questions about infection risk – a landmark study has been published that directly addresses the most critical concern raised in that coverage.
On May 21, 2026, researchers from the University of Southampton published a study in the International Journal of Nursing Studies demonstrating that reusable catheters are just as safe as single-use versions and do not increase the risk of urinary tract infections (UTIs). The 578-patient, 12-month randomized controlled trial found that patients using reusable catheters actually had a lower UTI rate (29 percent) than those using single-use catheters (34 percent), and used 35 percent fewer antibiotics.
This directly addresses the most significant concern raised in the May 19 article: infection risk. However, while the study provides independent validation of the reusable catheter concept, it does not answer all remaining questions about the specific Aurie system – pricing, VA rollout timing, and real-world durability remain unknown.
The study comes as the FDA’s De Novo authorization of the Aurie Reusable No-Touch Intermittent Catheter System™ (granted May 11, 2026) created an entirely new regulatory classification for reusable catheters. The Aurie system pairs a 100-use no-touch catheter with a portable washer-disinfector about the size of a small water bottle. The Veterans Health Administration has signaled interest in deploying the system through its spinal cord injury centers later this year.
The Essentials: Who, What, When, Where, Why, How (Last 72 Hours)
Who: University of Southampton researchers (lead author Professor Mandy Fader, co-author Margaret Macaulay, Professor Cathy Murphy); the National Institute for Health and Care Research (NIHR), which funded the study; 578 study participants; the NHS (UK health system); Aurie (US medical device company); the U.S. Food and Drug Administration; and approximately 500,000 Americans who use intermittent catheters regularly.
What: A landmark randomized controlled trial (RCT) comparing mixed-use (reusable/single-use) catheter management versus single-use catheter management for intermittent catheter users. The study found reusable catheters are non-inferior to single-use for UTI prevention, with a 29 percent UTI rate in the mixed-use group versus 34 percent in the single-use group.
When: The study was published on May 21, 2026, in the International Journal of Nursing Studies (DOI: 10.1016/j.ijnurstu.2026.105536). The research was conducted over a 12-month period with 578 participants.
Where: The study was conducted across multiple sites within the UK’s National Health Service (NHS). The findings have direct implications for the U.S. market, where the FDA recently authorized the first reusable catheter system.
Why (Immediate Cause): Prior to this study, there was a significant lack of high-quality evidence on the safety of reusable catheters. As Professor Mandy Fader stated: “Until now, there has been a real lack of high-quality evidence to support the reuse of catheters. But, with our study, we can say for the first time that it is a safe option to switch to reusable catheters.”
How (Mechanism): The study used a non-inferiority randomized controlled trial design. Participants in the mixed-use group were given a kit to wash reusable catheters in soap and water, followed by a soak in chlorine solution. The control group used single-use catheters exclusively. Researchers tracked UTI rates, antibiotic usage, and other outcomes over 12 months.
Specific Changes in the Last 72 Hours
1. Landmark Southampton Study Published (May 21, 2026)
On May 21, 2026, the International Journal of Nursing Studies published the MultICath trial – the largest and most rigorous study to date on reusable catheter safety.
Key Findings from the Southampton Study:
| Finding | Detail |
|---|---|
| Study size | 578 participants followed for 12 months |
| UTI rate (mixed-use group) | 29% experienced at least one UTI |
| UTI rate (single-use group) | 34% experienced at least one UTI |
| Antibiotic usage | 35% fewer antibiotics in reusable group |
| Cleaning protocol | Soap and water + chlorine solution soak |
| Conclusion | Reusable catheters are non-inferior to single-use for UTI prevention |
Lead author Professor Mandy Fader (University of Southampton) stated: “Until now, there has been a real lack of high-quality evidence to support the reuse of catheters. But, with our study, we can say for the first time that it is a safe option to switch to reusable catheters.”
Study co-author Margaret Macaulay added: “The NHS is full of single-use products, and many healthcare professionals caution against reusable items because of the risk of infection. However, our results clearly show that reusable catheters can and should be used by the NHS without increasing infection rates.”
Professor Marian Knight, NIHR Programme Director, noted: “This study is a powerful example of how NIHR-funded research could lead to real-world impact, improving patient choice, saving the NHS millions, and reducing plastic waste.”
Study Details: The full title of the study is “Mixed (reusable/single-use) catheter management versus single-use catheter management for intermittent catheter users (MultICath): A non-inferiority randomised controlled trial.”
2. Economic Impact: Potential Millions in Savings for Healthcare Systems
The study also quantified significant potential cost savings, directly addressing the economic questions raised in the May 19 article.
Professor Cathy Murphy (University of Southampton) explained: *“A box of 30 single-use catheters can cost about £50. Reusable catheters in our trial cost less than 10p per use and can be reused for a month. If just 25% of patients made the switch, the NHS could save millions.”*
Context on NHS Catheter Usage:
| Metric | Value |
|---|---|
| Annual single-use catheters prescribed by NHS | Approximately 100 million |
| NHS catheter costs (1998) | £22 million |
| NHS catheter costs (2026 projection) | £200 million |
| Reusable catheter cost per use (study) | Less than 10p |
| Single-use catheter cost per use (typical) | Approximately £1.67 |
This economic analysis is directly relevant to the US market. Medicare, Medicaid, and the Veterans Health Administration collectively spend billions annually on urological supplies. Similar savings could potentially be realized in the US if reusable catheters achieve comparable adoption rates.
3. Environmental Impact Quantified
The study also highlighted the environmental benefits of switching to reusable catheters.
Key environmental finding: “Thousands of tonnes of plastic waste” could be eliminated annually if reusable catheters are adopted.
Context: The NHS currently uses approximately 100 million single-use catheters per year. Switching to reusable options could dramatically reduce this plastic waste stream, aligning with broader healthcare sustainability initiatives referenced in the May 19 article (U.S. healthcare sector responsible for approximately 8.5 percent of U.S. carbon emissions).
4. Cleaning Protocol Validated
Importantly, the study validated a simpler cleaning protocol than the automated washer-disinfector used by the Aurie system.
Protocol for reusable group in the study: Participants were given a kit to wash catheters in soap and water, followed by a soak in chlorine solution.
This is significant because it suggests that reusable catheters can be safely cleaned with basic supplies (soap, water, chlorine) rather than requiring an expensive automated device. This could have implications for:
- Lowering the upfront cost barrier – Patients may not need to purchase an electronic washer-disinfector
- Expanding access in low-resource settings – Manual cleaning requires only electricity (for the soak? no – chlorine solution does not require electricity) and clean water
- Reducing complexity – Soap/water/chlorine may be simpler for some patients than operating an electronic device
However, the Aurie system uses an automated washer-disinfector with pre-packaged supply pods – a different cleaning method than the study’s manual protocol. The study validates the concept of reusable catheters, but does not specifically validate the Aurie device.
How This Addresses the May 19 Article’s Concerns
The May 19 article raised several important questions about the Aurie system. The Southampton study directly addresses many of these concerns, though some remain unanswered.
| Concern from May 19 Article | Addressed by Southampton Study |
|---|---|
| “Long-term infection rates in real-world use are unknown” | 12-month RCT with 578 patients provides real-world infection data |
| “Infection risk when patients do not follow cleaning protocols perfectly” | Study used patient-administered cleaning (soap/water + chlorine) with positive results |
| “Sample size and duration of clinical studies” | 578 patients over 12 months – substantial evidence base |
| “Differences in outcomes by patient population” | Diverse patient population across NHS settings |
| “Are reusable catheters cost-effective?” | Yes – less than 10p per use vs ~£1.67 per single-use |
| “What is the environmental impact?” | “Thousands of tonnes of plastic waste” could be eliminated |
However, the following concerns from the May 19 article are NOT addressed by the Southampton study:
| Unaddressed Concern | Reason |
|---|---|
| Aurie system pricing | Study conducted in UK with different products; Aurie pricing still unannounced |
| VA rollout timing | No US-specific information in UK study |
| Washer-disinfector cost | Study used manual cleaning, not automated washer-disinfector |
| 100-use durability claim | Study did not test durability to 100 uses |
| US reimbursement decisions | Study conducted in UK NHS, not US Medicare/private insurers |
Comparison: Before and After the Southampton Study
| Issue | As of May 19 Article | As of May 22, 2026 (Current) |
|---|---|---|
| Evidence for reusable catheter safety | Limited; FDA based on manufacturer testing | Large-scale RCT with 578 patients over 12 months |
| UTI risk comparison | Unknown; a key concern in the article | Lower UTI rate in reusable group (29% vs 34%) |
| Antibiotic usage comparison | Unknown | 35% fewer antibiotics in reusable group |
| Economic data | US-specific costs unknown; no large-scale economic analysis | UK data: reusable catheters <10p per use; potential millions in savings |
| Patient population evidence | Limited | 578 patients, real-world conditions |
| Cleaning protocol validation | FDA-cleared washer-disinfector required for Aurie | Study validates simpler soap/water + chlorine method |
| Environmental impact quantification | General statements about plastic waste | “Thousands of tonnes of plastic waste” estimate |
| Aurie system pricing | NOT ANNOUNCED | NOT ANNOUNCED (still unknown) |
| VA rollout timing | Expected “later this year” | Expected “later this year” (no change) |
Arguments For and Against (Updated for May 22)
In Favor of Reusable Catheters (Strengthened by New Evidence)
1. Safety Now Supported by Large-Scale RCT
The most significant change is the availability of high-quality evidence. Prior to May 21, reusable catheter safety was supported primarily by manufacturer testing. Now, a 578-patient, 12-month randomized controlled trial provides independent validation that reusable catheters do not increase infection risk and may actually reduce UTIs and antibiotic use.
2. Cost Savings Quantified
The study provides concrete economic data: reusable catheters cost less than 10p per use compared to approximately £1.67 per single-use catheter. If similar savings apply in the US market, the economic case for reusable catheters is substantially strengthened.
3. Environmental Benefits Quantified
“Thousands of tonnes of plastic waste” could be eliminated annually. This provides a concrete estimate of the environmental impact, moving beyond general statements about sustainability.
4. Simpler Cleaning Protocol Validated
The study’s use of soap/water + chlorine suggests that automated washer-disinfectors may not be necessary for safe reuse. This could lower the upfront cost barrier and expand access.
Against Reusable Catheters (Cautious Concerns Remain)
1. The Study Did Not Test the Aurie System
The Southampton study used a manual cleaning protocol (soap/water + chlorine). The Aurie system uses an automated washer-disinfector with pre-packaged supply pods. While both are reusable catheters, the specific devices and cleaning methods differ. The study validates the concept of reusable catheters but does not provide specific safety data on the Aurie device.
2. Pricing and Reimbursement Still Unclear
The study does not address US-specific pricing, reimbursement, or VA rollout. As of May 22, 2026, Aurie has still not announced pricing for the starter system, consumable pods, or the washer-disinfector. Medicare has not established a billing code. Private insurers have not announced coverage decisions.
3. Durability Claims Unverified
The study did not test durability to 100 uses. Aurie’s claim that the reusable catheter lasts for 100 uses remains unverified in real-world use. A catheter that fails after 50 uses is far less cost-effective.
4. Convenience Trade-Off Remains
The study does not address patient preferences or convenience. Reusable catheters require cleaning after each use, tracking remaining uses, and following protocols. For patients with limited hand function, cognitive impairment, or busy lives, this added complexity remains a real drawback.
5. Generalizability to US Population Unknown
The study was conducted in the UK NHS with UK patients. While the findings are likely generalizable, differences in healthcare systems, patient populations, and cleaning protocols mean that US-specific validation would be valuable.
What Has Not Changed: Single-Use Catheters Remain Available
The most important aspect of the May 19 article that remains unchanged is that single-use catheters remain fully available. The FDA has not banned disposable catheters, nor has it mandated the use of reusable alternatives.
Current Options for Patients (unchanged):
- Continue using single-use disposable catheters (any brand, any supplier)
- Choose the Aurie reusable system (when commercially available)
- Use a hybrid approach (reusable for daily use, single-use for travel or backup)
The Southampton study simply adds high-quality evidence supporting the safety of reusable catheters. It does not change the availability of single-use options.
Remaining Concerns (Updated for May 22)
1. Aurie System Pricing Still Unannounced
The most immediate practical concern from the May 19 article remains unchanged: Aurie has not announced pricing. Patients and healthcare systems cannot evaluate whether the Aurie system is cost-effective for their specific situation without knowing:
- The upfront cost of the starter system
- The per-use cost of consumable pods
- Whether and how insurers will cover the system
2. The Study Did Not Test the Aurie System
While the Southampton study provides strong evidence that reusable catheters can be safe, it did not test the specific Aurie system or its automated washer-disinfector. The Aurie system uses a different cleaning method (automated washer-disinfector with pre-packaged pods) than the study’s manual protocol (soap/water + chlorine).
3. VA Rollout Timing Still Vague
The Veterans Health Administration has signaled interest in deploying the Aurie system through its network of spinal cord injury centers, but specific timing remains unclear. As of May 22, launch is still expected “later this year” with no specific date announced.
4. US-Specific Economic Data Still Lacking
The study provides UK-specific economic data (less than 10p per use). US-specific costs – including the Aurie system’s pricing, Medicare reimbursement rates, and private insurer coverage decisions – remain unknown.
5. No Competitor Pipeline Yet Public
While the FDA’s creation of a new device classification theoretically opens the market to competitors, no other manufacturer has announced a reusable catheter in development for the U.S. market. Aurie will likely have market exclusivity for at least 12-24 months.
Why This Matters (Updated for May 22)
The Southampton study is not niche academic research. It matters to patients, taxpayers, and anyone concerned about healthcare sustainability for several reasons:
For patients who use catheters: The study provides high-quality evidence that reusable catheters are safe. A patient who was concerned about infection risk can now point to a 578-patient, 12-month RCT showing lower UTI rates (29% vs 34%) and 35% fewer antibiotics in the reusable group. This evidence may influence patient decisions and physician recommendations.
For family members of catheter users: Caregivers who were concerned about infection risk from reusable devices now have evidence that patient-administered cleaning (soap/water + chlorine) is effective. This may make reusable catheters a more attractive option for home care.
For taxpayers: The study quantifies potential savings: reusable catheters cost less than 10p per use compared to approximately £1.67 per single-use catheter. If similar savings apply to Medicare, Medicaid, and the VA, the cumulative savings to US taxpayers could reach hundreds of millions of dollars annually.
For anyone concerned about healthcare sustainability: The study estimates that “thousands of tonnes of plastic waste” could be eliminated annually. This provides concrete evidence for the environmental case for reusable catheters.
For healthcare systems considering reusable catheters: The study provides the high-quality evidence needed to make informed purchasing and coverage decisions. Prior to May 21, reusable catheter safety was supported primarily by manufacturer testing. Now, independent RCT evidence is available.
The bottom line: The Southampton study represents a significant step forward in the evidence base for reusable catheters. It directly addresses the infection risk concerns raised in the May 19 article and provides quantitative estimates of cost savings and environmental benefits. However, it does not answer all remaining questions about the specific Aurie system – pricing, VA rollout timing, and real-world durability remain unknown. The next 12-24 months of post-market experience with the Aurie system will determine whether the FDA’s quiet authorization becomes a landmark moment in medical device regulation or a cautionary tale.
Current Status (As of May 22, 2026)
| Element | Status |
|---|---|
| Southampton MultICath trial | PUBLISHED May 21, 2026 in International Journal of Nursing Studies |
| Study finding on UTI risk | Reusable catheters non-inferior; 29% UTI rate vs 34% for single-use |
| Study finding on antibiotics | 35% fewer antibiotics in reusable group |
| Study finding on cost | Reusable <10p per use vs ~£1.67 single-use |
| FDA De Novo authorization (Aurie) | GRANTED (May 11, 2026) – unchanged |
| Aurie system pricing | NOT ANNOUNCED – unchanged |
| Commercial availability | NOT YET – unchanged |
| VA rollout | EXPECTED “LATER THIS YEAR” – unchanged |
| Medicare coverage decision | PENDING – unchanged |
| Competitor announcements | NONE – unchanged |
| Does the study test the Aurie system? | NO – study used manual cleaning, not automated washer-disinfector |
Sources
- University of Southampton (May 21, 2026) – Press release: “Reusable catheters just as safe as single-use, study finds.” Available at: southampton.ac.uk/news
- International Journal of Nursing Studies (May 21, 2026) – “Mixed (reusable/single-use) catheter management versus single-use catheter management for intermittent catheter users (MultICath): A non-inferiority randomised controlled trial.” DOI: 10.1016/j.ijnurstu.2026.105536
- National Institute for Health and Care Research (NIHR) – Funding acknowledgment for the MultICath trial.
- Previous article: FDA Authorizes First Reusable Catheter After 50 Years of Disposables – But Washer-Disinfector Cost Remains Unclear (The 5 Ws, May 19, 2026) – Baseline information on FDA authorization, Aurie system, VA rollout plans, and remaining concerns.
The 5 W's 
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