Urinary tract infections after catheter removal are a frequent complication associated with multiple morbidities and longer lengths of hospital stay.
For providers, they are also a source of judgment calls on antibiotic usage that must be made in a gray zone of unknowable factors. The provider must weigh the risks on either side of the decision, considering the patient’s health status and history, and best guesses on which pathogens to target and with what antibiotics while awaiting culture results.
Reconstructive urologist Hiren Patel, MD, PhD, at The Ohio State University Wexner Medical Center, has had a career-long interest in antibiotics and the global threat of antibiotic resistance. He is currently leading a trial on using chlorhexidine lavage to irrigate the urinary tract prior to catheter removal.
“When I saw the opportunity to use this product that we use pretty commonly in the operating room to reduce infections, it caught my attention,” Dr. Patel says. “It’s not a conventional antibiotic, but a powerful disinfectant that may make catheter removal clean and prophylactic antibiotics unnecessary.”
The chlorhexidine lavage is categorized by the FDA as a medical device, not a prescription. As such, Dr. Patel approached irrigation device manufacturer Irrimax, Inc. with the idea of sponsoring a trial on this approach.
Risky judgment calls
“Whenever we do these catheter removals, much of the time we prophylactically give them antibiotics even if they don't show any signs of infection. This is particularly prevalent in patients who are considered high-risk,” Dr. Patel says. “If they do have symptoms like burning and aching with urination, we still have to roll the dice a bit, because we don’t know what the pathogen is until the culture is back two to three days later.”
With this prophylactic approach comes both the larger concern about propagating antibiotic resistance and the fact that many patients are subjected to antibiotic side effects unnecessarily.
“Broad-spectrum antibiotics like Bactrim, Levaquin, ciprofloxacin and Macrobid provide good coverage of uropathogens, but for every one of these antibiotics, every time you give it, there's a side effect profile that's associated with that decision,” Dr. Patel says. “So, are you hurting someone's GI tract or causing resistance? Are you risking the development of C. diff and other intractable chronic infections with trials of multiple antibiotics until one works?”
Practice comparison trial underway
The Irrimax trial is a randomized, controlled trial, with accrual of between 260 and 300 patients. Patients are assigned to a chlorhexidine arm or a standardized protocol arm. The provider can give prophylactic antibiotics as they normally would, whereas patients in the lavage arm receive no other antibiotics at that point.
“The trial will include patients who have had procedures for urinary retention, urethral strictures and ongoing issues that require catheterization,” Dr. Patel says.
Physicians and nurses instill the fluid through the catheter, allow a dwell time of three minutes in the bladder and then remove the catheter. At 14 and 30 days following the lavage, patients are asked if they have symptoms of a urinary tract infection. If they do, the patient receives a urine culture and targeted treatment of the infection, if needed.
An uncomplicated translation
Following positive outcomes with the enrolled patients, individual providers are free to adopt the chlorhexidine lavage method.
“Pending outcomes that show it does reduce infection rates, I plan to implement it immediately with my patients. If we have robust results, I expect it will be adopted for catheterized individuals in various settings, including hospitals, outpatient and possibly at home,” Dr. Patel says.