Protocol for a prospective neuroimaging study investigating the supraspinal control of lower urinary tract function in healthy controls and patients with non-neurogenic lower urinary tract symptoms

INTRODUCTION: Lower urinary tract symptoms (LUTS) are highly prevalent, cause an enormous economic burden on healthcare systems and significantly impair the quality of life (QoL) of affected patients. The dependence of the LUT on complex central neuronal circuits makes it unique in comparison to other visceral functions, such as the gastrointestinal tract, but also more vulnerable to neurological diseases. METHODS AND ANALYSIS: This is a prospective neuroimaging study investigating the supraspinal control of LUT function in healthy controls and in patients with non-neurogenic LUTS. The clinical assessment will include medical history, neuro-urological examination, bladder diary, urine analysis, urodynamic investigations, as well as standardised questionnaires regarding LUTS and QoL. The acquisition of neuroimaging data will include structural assessments (T1-weighted imaging and diffusion tensor imaging) as well as functional investigations using blood-oxygen-level dependent sensitive functional MRI (fMRI) in a 3 T MR scanner. The fMRI will be performed during four different bladder tasks using an automated MR-compatible and MR-synchronised pump system. The first three task-related fMRIs will consist of automated, repetitive filling of 100 mL warm (37°C) saline starting with (1) an empty bladder, (2) a low prefilled bladder volume (100 mL) and (3) a high prefilled bladder volume (persistent desire to void). The fourth task-related fMRI will comprise of automated, repetitive filling of 100 mL cold (4–8°C) saline starting with an empty bladder. ETHICS AND DISSEMINATION: The local ethics committee approved this study (KEK-ZH-Nr. 2011–0346). The findings of the study will be published in peer-reviewed journals and presented at national and international scientific meetings. TRIAL REGISTRATION NUMBER: This study has been registered at clinicaltrials.gov (http://www.clinicaltrials.gov/ct2/show/NCT01768910).