Flexible URS found safe, effective in stones

Hanover, NH-Flexible ureteroscopy is a safe and highly effective approach for treating proximal ureteral stones measuring <2 cm, according to the findings of a multi-institutional, prospective clinical trial.

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Conducted at 10 large stone treatment centers and using very strict entry criteria, the study enrolled 69 patients over a period of 2 years. Eligible patients were adults with a solitary proximal ureteral calculus <2 cm and without concomitant ipsilateral renal calculi or prior ureteral stenting. They were treated using flexible ureteroscopy with Holmium laser lithotripsy and ureteral stent placement.

Outcomes showed the procedure was associated with low morbidity and a high stone-free rate. Based on follow-up at 4 to 6 weeks post-treatment in 62 patients who returned for follow-up, the stone-free rate was 95%.

Dr. Hyams“Both a recent systematic review of the literature [J Urol 2012; 188:130-7] and the AUA guidelines on treatment of ureteral stones conclude there is inadequate evidence to make any recommendation on the use of ureteroscopy versus ESWL for the management of proximal ureteral calculi <2 cm. This prospectively designed single-arm trial was undertaken to establish the benchmark efficacy of flexible ureteroscopy for these particular stones,” explained first author Elias Hyams, MD, assistant professor of surgery at Geisel School of Medicine, Dartmouth College, Hanover, NH.

Benchmark for future research

“Our results show excellent clinical outcomes, and we believe our data can be used for comparing results with other techniques in future studies and to inform the debate on the optimal management of these stones,” Dr. Hyams said of the study, which was presented at the 2014 AUA annual meeting in Orlando, FL and subsequently published in the Journal of Urology (2015; 193:165-9).

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Dr. Hyams noted that the strict entry criteria used for patient selection in the prospective trial account for the prolonged 2-year patient accrual period and speak to the methodologic challenges of collecting very rigorous evidence in a homogenous population.

He also observed that most, if not all, previous series reporting on outcomes of ureteroscopy for treatment of proximal ureteral stones have been based on use of rigid or semirigid instrumentation.

“There are many published single-arm series of ESWL for the treatment of proximal ureteral calculi <2 cm, and the authors of some of those papers concluded their outcomes were similar to ureteroscopy. However, their comparisons were not for flexible ureteroscopy that allows for retrieval of fragments retropulsed into the kidney and results in higher stone-free rates than are achieved using older rigid or semirigid technology,” Dr. Hyams said.

He acknowledged that the stone-free rate in the study might have been lower if clearance was based on assessment with a computed tomography scan. However, the methodology used, evaluation with ultrasound and KUB, is more consistent with real-world practice, Dr. Hyams said.

The patients in the prospective study had a mean age of about 49 years and mean body mass index of about 32 kg/m². Mean stone size was 7.4 mm (range, 5 to 15 mm), and mean surgical time was about 60 minutes (range, 15 to 148 minutes).

An access sheath was used in two-thirds of the cases. Its use as well as specific laser settings and other details of perioperative and postoperative management were left to the discretion of the treating urologist.

The only intraoperative complication encountered was mild ureteral trauma (2.8%). Postoperative adverse events included urinary tract infection (4.3%), urinary retention (2.8%), and flash pulmonary edema (1.4%).

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