Clinical Study Design for Medical Devices Treating Urinary Incontinence
This guidance addresses the general clinical study design concepts for medical devices indicated for the treatment of urinary incontinence. It covers both Class I, II and III devices, with a focus on clinical investigations to support marketing submissions (510(k)) or applications (PMA). The guidance does not address preclinical testing issues.
Recommended Actions
- Develop detailed clinical investigation protocol including:
- Clear study objectives and hypotheses
- Patient selection criteria
- Pre-treatment evaluation requirements
- Treatment procedures
- Follow-up schedule and evaluations
- Primary and secondary endpoints
- Statistical analysis plan
- Conduct pilot study before pivotal study to:
- Gain clinical experience
- Refine study procedures
- Validate endpoints
- Estimate sample size
- For pivotal study:
- Use randomized controlled design
- Include multiple clinical sites
- Follow subjects for at least 1 year
- Implement measures to minimize bias
- Monitor study conduct closely
- Document all data in case report forms
- Develop comprehensive monitoring plan and procedures
- Create detailed case report forms to capture all required data
- Plan for statistical analyses including handling of missing data
- Consider post-market follow-up requirements during study design
Key Considerations
Clinical testing
- Randomized controlled trial is recommended as the least burdensome means of collecting data
- Study duration should be at least 1 year for devices intended as curative treatment or long-term management
- Multi-center study recommended to assess consistency across investigators and patient populations
- Pilot study recommended before pivotal study
- Primary effectiveness endpoints should be:
- Reduction in urine leakage via pad weight testing
- Reduction in number of incontinence episodes per day
Human Factors
- Subject training required for proper completion of voiding diaries
- Clear instructions needed for pad weight testing procedures
- Patient satisfaction surveys recommended
Labelling
- Clear documentation of indications for use based on urinary incontinence categories studied
- Documentation of any limitations based on patient population studied
- Documentation of training requirements
Safety
- Record all adverse events regardless of device relationship
- Categorize events by relatedness to device/procedure and severity
- Document onset and resolution of adverse events
- Safety analysis should include descriptive assessment of types and frequency of adverse events
Other considerations
- Patient selection criteria must be clearly defined
- Pre-treatment evaluation requirements specified
- Post-treatment follow-up schedule and evaluations defined
- Statistical analysis plan must be comprehensive and pre-specified
- Study monitoring procedures required
- Case report forms needed to document all study data
Relevant Guidances
- Design Considerations for Medical Device Pivotal Clinical Studies
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- IDE Clinical Investigation Decision Process and Requirements
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
Related references and norms
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 56: Institutional Review Boards
Original guidance
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