Premium
New technology assessment and current and upcoming therapies for underactive bladder
Author(s) -
Chancellor Michael B.,
Bartolone Sarah N.,
DeVries Elise M.,
Diokno Ananias C.,
Gibbons Mark,
Jankowski Ronald,
Lamb Laura E.,
Pruchnic Ryan,
Thor Karl,
Dmochowski Roger
Publication year - 2018
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.23738
Subject(s) - medicine , clinical trial , overactive bladder , inclusion and exclusion criteria , quality of life (healthcare) , intensive care medicine , alternative medicine , nursing , pathology
Background and Aims Stakeholders from around the world came together to address the unmet needs of underactive bladder (UAB) at the 3rd International Congress for Underactive Bladder. Methods The main recommendation from the regulatory working group is a need for a meeting of UAB stakeholders and regulatory agencies including the FDA to discuss guidance for regulatory trial design for devices, drugs, and/or biologics for UAB. Results The following issues to be discussed and agreed upon for UAB trials: 1) Appropriate inclusion and exclusion criteria. 2) Should residual urine volume be the primary outcome parameter and how often should it be measured? 3) Are there secondary measures that should have a place in UAB trials, such as change in the number of catheterizations, quality of life measures, etc.? 4) Use and format of bladder voiding and catheterization diary for trials. 5) Define role and technique of urodynamics in UAB trials. Are urodynamics required to monitor, and possibly exclude, individuals with high pressure voiding induced by bladder prokinetic therapies? 6) Development and use of UAB questionnaires. Discussion and Conclusion The UAB regulatory working group recognizes the path forward should include engaging the FDA and other regulatory organizations that may harmonize and formalize guidance for regulatory trial designs for therapeutics for UAB.