Implantable bladder sensors for real-time urodynamics: A systematic review of preclinical and clinical evidence in neuro-urology.

BACKGROUND: Catheter-based urodynamic studies remain the standard for diagnosing lower urinary tract dysfunction, but are limited by discomfort, infection risk, and restricted monitoring duration. Emerging implantable bladder sensors offer the potential for real-time wireless pressure monitoring without the need for catheters, with promising applications in neurology. This study was aimed to systematically review and compare the performance, safety, and translational readiness of intravesical and submucosal implantable bladder sensors used for real-time urodynamic assessments in preclinical and clinical studies. MATERIALS AND METHODS: A systematic literature search was conducted in PubMed, Scopus, and IEEE Xplore from their inception to July 10, 2025, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies that evaluated wireless implantable bladder pressure sensors in animal or human models were included. Data on the pressure fidelity, biocompatibility, implantation site, and signal stability were extracted and compared. RESULTS: Four studies met the inclusion criteria: 3 preclinical studies (rabbit or pig) and 1 human feasibility trial. Intravesical sensors showed superior pressure fidelity (correlation coefficients up to r = 0.885), minimal error (±1 cm H2O), and favorable safety with no adverse effects. In humans, the UroMonitor device demonstrated an event-detection accuracy of 98% and was well tolerated. Submucosal devices achieved high event-specific correlations (r = 0.75-0.94) but were limited by erosion and signal degradation. Heterogeneity in sensor design, implantation duration, and biocompatibility has limited direct comparisons. CONCLUSIONS: Intravesical implantable sensors demonstrated higher accuracy, safety, and translational readiness than submucosal alternatives. The success of the UroMonitor in human feasibility studies underscores its potential for catheter-free ambulatory bladder pressure monitoring. Future studies should focus on long-term implantation, artificial intelligence integration, and comparative trials using conventional urodynamics.