Abstract
Artificial intelligence (AI) is poised to improve the diagnosis and management of lower urinary tract dysfunction (LUTD). Its effective deployment requires prioritization, regulatory oversight, rigorous validation, and clinician and patient engagement.
The Think Tank at the International Consultation on Incontinence-Research Society (ICI-RS) 2025 evaluated key considerations for successful AI implementation into LUTD clinical care. The topics included clinical triage framework, regulatory and legal principles, levels of evidence required for validation, and clinician and patient engagement to guide development. The group developed a narrative of the pressing matters related to AI implementation and a list of proposed research questions, which, when addressed, will help shape the future of the field.
LUTD topics that should be prioritized for AI implementation include high-burden conditions with high unmet need such as neurogenic LUTD, bladder outlet obstruction, and overactive bladder. Regulatory frameworks such as the EU AI Act and the U.S. "Software as a Medical Device" and its associated guidance promote safety, transparency, and accountability. AI solutions should be as rigorously evaluated as other clinical devices or drug agents. Patient and clinician engagement are paramount to ensure innovation aligns with the pressing needs of patients and clinicians.
AI's integration into LUTD care requires cross-disciplinary collaboration, prospective validation, and legal and ethical frameworks. AI must be developed and implemented with a strong focus on transparency, trust, and patient-centered care.
This study is not a clinical trial and thus does not warrant registration as such.