A protocol for developing, disseminating, and implementing a core outcome set for stress urinary incontinence.

Area of Science:

• Urogynecology
• Clinical Trials Methodology
• Patient-Reported Outcomes

Background:

• Inconsistent outcome measures in stress urinary incontinence (SUI) trials limit research impact.
• Outcome reporting flaws hinder the translation of research findings into clinical practice.
• A standardized approach is needed to ensure consistent and comprehensive outcome reporting.

Purpose of the Study:

• To develop a consensus-based Core Outcome Set (COS) for stress urinary incontinence (SUI) trials.
• To ensure outcomes important to patients and clinicians are consistently reported.
• To enhance the utility of research for clinical practice and patient care.

Main Methods:

• An international steering group will guide COS development.
• Literature reviews will identify potential outcomes.
• An international online Delphi survey with key stakeholders (patients, clinicians, researchers) will achieve consensus.

Main Results:

• Consensus on a standardized set of core outcomes for SUI research will be achieved.
• The COS will provide a consistent framework for outcome measurement.
• This will facilitate comparison across studies and improve evidence synthesis.

Conclusions:

• Implementation of the COS in future SUI trials, reviews, and guidelines will enhance research value.
• Standardized outcomes will improve clinical practice, patient care, and treatment effectiveness.
• The developed infrastructure can support other research priority settings.