Clinical trials of the surgical management of urolithiasis: current status and future needs.

We reviewed the literature on the surgical treatment of urolithiasis. All prospective, randomized trials on the surgical treatment of stone disease were reviewed. Percutaneous nephrolithotomy (PNL) is superior to shockwave lithotripsy (SWL) or open surgery in the treatment of staghorn calculi. For ureteral stones, ureteroscopy appears to result in a higher stone-free rate and lower need for retreatment compared with SWL but has a higher complication rate and increased hospital stay. For lower pole renal calculi, PNL results in a higher stone-free rate and lower need for retreatment compared with SWL but has a higher complication rate and increased hospital stay. Most areas of surgical stone treatment have been addressed by a randomized controlled trial; however, most trials were of poor quality. Trials tend to focus only on radiologic outcomes. No study to date has been able to show a measurable quality of life benefit to patients, possibly because no condition-specific quality of life instruments have been developed. In addition, economic impact, both direct and indirect, has been rarely characterized. The surgical treatment of kidney stones is poorly researched. Future trials should be performed with adequate funding and patient-focused outcomes.