What research is needed to validate new urodynamic methods? ICI-RS2017

Area of Science:

• Urology
• Medical Device Development
• Clinical Trials

Background:

• Urodynamic innovations lack standardized clinical trial pathways for efficacy demonstration.
• The International Consultation on Incontinence Research Society (ICI-RS) identified the need for minimum standards in urodynamic research.

Purpose of the Study:

• To review the IDEAL collaboration's recommendations for surgical research.
• To critique the research programs of novel urodynamic technologies using case studies.
• To endorse a standardized model for future urodynamic research.

Main Methods:

• Reviewed IDEAL collaboration recommendations for surgical research.
• Critiqued research programs of two novel urodynamic technologies: penile cuff test and air charged urodynamic catheters.
• Applied the IDEAL framework as a template for development and assessment.

Main Results:

• Endorsed the IDEAL collaboration's rigorous and standardized model for urodynamic research.
• The penile cuff test, a novel urodynamic technique, is well-researched and in clinical practice.
• Air charged urodynamic catheters require further research before widespread clinical adoption, with the IDEAL framework guiding ongoing development.

Conclusions:

• The proposed recommendations will foster a more standardized urodynamic research program.
• This standardization will enable thorough evaluation of new urodynamic technologies before clinical implementation.
• Ensuring a methodical approach to research will improve the design, refinement, and efficacy proof of new urodynamic tests and devices.