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New technology assessment and current and upcoming therapies for underactive bladder
Michael B Chancellor1, Sarah N Bartolone1, Elise M DeVries2
1Department of Urology, Beaumont Health System, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.
Neurourology and Urodynamics
|June 29, 2018
Summary
International experts convened to address underactive bladder (UAB) needs. A key recommendation is a stakeholder meeting with regulatory agencies like the FDA to standardize trial designs for UAB treatments.
Area of Science:
- Urology
- Regulatory Science
Background:
- Underactive bladder (UAB) presents significant unmet needs.
- The 3rd International Congress for Underactive Bladder convened global stakeholders to address these challenges.
Purpose of the Study:
- To establish a consensus on critical issues for designing regulatory trials for UAB therapeutics.
- To propose a collaborative approach involving stakeholders and regulatory bodies.
Main Methods:
- Convening of a regulatory working group at the international congress.
- Discussion and identification of key parameters for UAB clinical trial design.
Main Results:
- Identified essential topics for UAB trial design, including inclusion/exclusion criteria, outcome measures (residual urine volume, catheterizations, quality of life), diary use, urodynamics, and questionnaires.
- Recommended a formal meeting with regulatory agencies like the FDA.
Conclusions:
- Engagement with the FDA and other regulatory organizations is crucial.
- Harmonizing and formalizing guidance for UAB therapeutic trial designs is necessary for advancing treatment development.
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