Clinical investigation of medicinal products in the treatment of urinary incontinence - Scientific guideline

This document considers pharmacodynamic and clinical data required to support indications, dose regimens and durations of therapy for the treatment of urinary incontinence.

Keywords: Urinary incontinence

Current effective version

Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence

Adopted Reference Number: CPMP/EWP/18/01/Rev. 1

Document history

Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence

Adopted Reference Number: CPMP/EWP/18/01/Rev. 1

Draft guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence (revision 1)

Draft: consultation closed Consultation dates: 20/11/2011 to 31/05/2012 Reference Number: CPMP/EWP/18/01/Rev. 1

Overview of comments received on the guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence

Reference Number: EMA/CHMP/107622/2013

Concept paper on the need for revision of the Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence (CPMP/EWP/18/01)

Draft: consultation closed Consultation dates: 22/04/2010 to 31/07/2010 Reference Number: EMA/CHMP/EWP/68523/2010

Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence

Adopted Reference Number: CPMP/EWP/18/01 final Legal effective date: 01/06/2003