Benign Conditions

We recap notable headlines from last month in the benign urology space.

A recap of the FDA submissions and regulatory decisions in urology from September 2025.

The device features a 12 French working channel, the largest of any flexible single-use cystoscope.

A comprehensive guide to the key regulatory decisions and conferences slated for the last few months of the year.

Data showed a marked or moderate improvement in IC/BPS symptoms in 41% of patients who received sunobinop vs 9% of patients who received placebo.

The approval of oral sulopenem was supported by data from the phase 3 SURE 1 (NCT03366207) and REASSURE (NCT05584657) trials.

The target action date for the application is December 11, 2025.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea.

These data are intended to support a new drug application to the FDA in the second half of 2025.

A recap of the FDA submissions and regulatory decisions in urology from April 2025.

The method involves local delivery of the antibiotic gentamicin directly into the bladder tissue.

Check out the key regulatory decisions set to happen early this year.

In a recent study of the RELIEF stent, 95% of patients showed no VUR following stent placement.

"The goal for this study was to understand, over the lifetime in individuals with spina bifida, what bacteria are present in their urine normally, what bacteria are present when they have a UTI, and what are some important clinical differences we can tease out to help understand which patients should really be treated," says Brendan T. Frainey, MD.

Catch up on all the notable drug and device approvals in urology over the past year.

A rapid reduction in E coli in the urine was observed among 10 of 16 evaluable patients at 4 hours following the first treatment.

The approval is supported by data from the phase 3 SURE 1 and REASSURE trials.

According to iota Biosciences, the device is “designed to deliver electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder emptying in individuals impacted by underactive bladder.”

"One of the things I think that's really interesting is we're seeing the development of a lot of AI predictive models of who might progress to urosepsis and who might be at higher risk for progression of their infection to have greater health consequences," says A. Lenore Ackerman, MD, PhD.

“What probably should be happening is that we should be reserving these antibiotics only for those situations in which someone has a multi-drug-resistant infection for which there are options that are not available otherwise,” says A. Lenore Ackerman, MD, PhD.

"A global consensus on standardization of terminology, separation of LUTS vs pain for outcome, HL positivity and negativity, markers for disease, and the role of new interventions for local vs systemic therapy is needed," writes Gopal H. Badlani, MD.

"It's really upon us, as the medical community, to be better about not just antibiotic stewardship, but also diagnostic stewardship," says A. Lenore Ackerman, MD, PhD.

Follow Urology Times' coverage of the full-day FDA advisory committee meeting regarding Iterum Therapeutics' new drug application for oral sulopenem for uncomplicated urinary tract infection.

“We are finding more and more information and evidence to support recommendations to try and reduce the infection rates,” says Christian Moro, PhD, BSc, BEd, MBus, SFHEA.