Key ongoing clinical trials take center stage at AUA2024
Researchers reported on 12 clinical trials in the Learning Lab on Friday.

“Clinical Trials in Progress: Benign Disease” opened Friday afternoon with a glimpse at a new sheath for nephrolithiasis. Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis compares a novel sheath that allows surgeons to irrigate and suction simultaneously. Based on the mini-PCNL, the pilot study showed greater stone-free rate, less operative time, lower intrarenal pressure and fewer complications compared to conventional sheaths.
“We have enrolled 20% of our target of 90 patients,” said Sri Sivalingam, MD, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, “but it is too early to have data to report.”
RELIEF, the Reduced-dose onabotulinumtoxinA for Urgency Incontinence Among Older Females, compares 50 IU injections of Botox into the detrusor muscle versus the standard 100 IU in older women with urge incontinence. Quality of life is the primary outcome; secondary outcomes include comparisons of clinical and patient-reported outcomes.
“Patients are often concerned about cost. We clinicians are concerned about side effects,” said E. Ann Gormley, professor of urology surgery at Dartmouth Hitchcock Clinic. “RELIEF addresses both concerns.”
Enrollment opened in May 2023 with 174 patients as of April 2024, and will close April 2025 at 376.
Multiple observational trials suggest that exercise improves outcomes for older men with urinary disease, but there are few randomized controlled trials. The Prescription exercise for Older men with Urinary Disease (PROUD) trial is comparing the effect of receiving information on exercise versus information plus active exercise coaching. Endpoints include the rate and intensity of physical exercise plus patient-reported and clinical changes in body measurements, lab measurements and urologic function.
PROUD is targeting 68 participants, said Stacey A. Kenfield, SM, ScD, professor of epidemiology and biostatistics at the University of California in San Francisco, and is actively seeking partners for a multicenter trial.
“We have a real shortage of randomized controlled data,” Dr. Kenfield said. “We have our first 15 patients, so if you have patients in the community who might be appropriate, please refer them!”
AUA guidelines recommend stent omission after uncomplicated ureteroscopy, yet 80% of U.S. ureteroscopy patients are stented. A 2019 Cochrane Review article noted that stenting may slightly reduce the number of unplanned visits.
“The Cochrane data are uncertain,” said Khurshid Ghani, MBChB, MS, FRCS, University of Michigan Urological Surgery Improvement Collaborative. “We need a good randomized clinical trial.”
Stent Omission after Ureteroscopy and Lithotripsy (SOUL) is a patient-centered comparative effectiveness trial of stent versus no stent following uncomplicated ureteroscopy. The trial has recruited 50 of a planned 125 patients for the two-year, 14 center trial. Patients who want to participate but are not willing to undergo randomization can enroll in an observational arm, a first in this population. Dr. Ghani said SOUL results are expected to guide surgical practice nationally.
Other trials are exploring the benefits of treating small, asymptomatic stones in the office, using hydration to prevent urinary stones, holmium-YAG versus Thulium fiber laser for dusting stones, an investigational drug to block bladder pain and multiple new treatments for erectile dysfunction.