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.