Lessons learned from conducting a multi-center lower urinary tract physiology study: the LURN experience.

Purpose: To document the logistics and technical considerations of a multi-center protocol evaluating the sensory and motor function of both the bladder and the urethra, in women with urgency only, urinary urgency with incontinence, and controls. Methods: The study network organization and infrastructure are described, with attention to the technical training methods and continuous data quality control. Results: The LURN Organ study was approved in March 2020 and enrolled participants from March 2021 - November 2023, through the COVID pandemic. One hundred five participants were enrolled from all 6 research sites and completed the study testing protocol with no adverse events. All participants had evaluable data, and the majority of the participants had evaluable data from all 4 lower urinary tract (LUT) tests of the protocol. One test cohort did not reach the target enrollment adequate for statistical analysis. The lessons of a pilot study and technical practice; virtual training for a LUT physiology study; early, continuous technical and data quality control; diverse expertise within the research team, and under-enrollment in one cohort are discussed. Conclusions: The conduct of a large, multi-site extended lower urinary tract physiology study is necessarily complex, resource-intensive, and fraught with possible pitfalls. The lessons learned by the LURN-Organ study group, particularly in the context of unprecedented circumstances, will hopefully help and inspire future investigators to continue this much-needed clinical research in LUT function.