Hypothesis / aims of study
Overactive bladder (OAB) impairs quality of life and has significant personal and financial burdens. OAB is most prevalent in the aging population and adults with co-morbidities, posing challenges in medical and surgical management. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation therapy to affect regional brain functional connectivity (FC). In this single-arm pilot trial (ClinicalTrials.gov ID: NCT06198439), we investigated the safety and therapeutic effects of neuronavigated rTMS on the voiding brain subnetwork involved in OAB by targeting two brain regions using neuronavigation. We hypothesized that clinical measures of OAB correlate with changes in brain FC.
Study design, materials and methods
Thirteen adults (12 female) with idiopathic OAB reporting a minimum of 8 voids and 3 urge episodes/24 hours on bladder diaries completed a natural bladder filling resting state functional magnetic resonance imaging (rsfMRI) protocol before and after rTMS for comparison of FC during empty and full bladder-states. Participants completed five daily forty-minute rTMS sessions targeting individuals’ bilateral pelvic supplemental motor area (SMA) and right dorsolateral prefrontal cortex (rt dlPFC) specifically. Overactive Bladder Questionnaire-Short form symptom bother score was assessed at baseline and immediately after rTMS completion (Post-TMS OABq Symptom bother score). Clinical responders to rTMS were defined as a reduction of 20 points from baseline to post-TMS OABq symptom bother score.
Mean relative change of functional connectivity (rFC, range 0-1) in the rTMS targets (SMA and dlPFC) was assessed using a t-test. In addition, individual FC in the voiding subnetwork post stimulation (post-TMS) were compared to the immediately Post-TMS OABq Symptom bother score using linear regression. Clinical responders were defined as a reduction of 20 points from baseline to post-TMS OABq symptom bother score. P-values <0.05 were considered significant.
Interpretation of results
rTMS effectively and safely modulated FC in brain regions of the voiding subnetwork involved in OAB. In particular, a strong statistically significant correlation was found between clinical outcome and FC in selected brain regions post-TMS, indicating clinical efficacy of rTMS.