Clinical Investigation of Medical Devices for Treatment of Urinary Incontinence
This guidance document addresses general clinical study design concepts for medical devices indicated for the treatment of urinary incontinence. It covers both Class I, II and III devices but focuses mainly on clinical investigation aspects rather than preclinical testing. The guidance indicates when clinical data may be needed for Class I and II devices and confirms that clinical data is required for Class III devices through PMAs.
What You Need to Know? 👇
What are the key challenges in designing clinical studies for urinary incontinence devices?
Clinical studies for urinary incontinence devices face unique challenges including inherent variability and subjectivity of outcome measures, significant placebo effects, and heterogeneous patient populations that can introduce bias if not properly controlled.
Which primary effectiveness endpoints does FDA recommend for urinary incontinence device studies?
FDA recommends using reduction in urine leakage assessed by pad weight testing and/or reduction in number of incontinence episodes per day. Both should define dryness and clinically meaningful improvement (>50% reduction from baseline).
What study design does FDA generally recommend for urinary incontinence device investigations?
FDA generally recommends randomized, controlled trials as the least burdensome means to demonstrate safety and effectiveness. This design balances patient covariates, permits assessment of placebo effects, and provides reliable assessment of subjective outcome measures.
How long should the follow-up period be for urinary incontinence device studies?
FDA recommends following subjects for 1 year following treatment to document stability of treatment effect. Longer follow-up may be appropriate depending on device-specific factors like material properties or retreatment requirements.
What are the requirements for conducting clinical studies of urinary incontinence devices?
Studies must be conducted under IDE regulations (21 CFR Part 812) for significant risk devices, with compliance to institutional review board regulations (21 CFR Part 56) and informed consent requirements (21 CFR Part 50).
What patient selection criteria should be considered for urinary incontinence device studies?
Key criteria include specific incontinence category diagnosis, objectively measured severity, appropriate age range, failed conservative therapies, and exclusion of confounding conditions like prominent pelvic organ prolapse or neurological disorders.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive clinical investigation protocol including:
- Clear study objectives and statistical hypotheses
- Patient selection criteria
- Primary and secondary endpoints
- Risk analysis and monitoring procedures
- Case report forms
- Plan for pilot study followed by pivotal study with:
- Minimum 1 year follow-up
- Multiple clinical sites
- Randomized controlled design where possible
- Implement robust data collection procedures for:
- Baseline assessments
- Treatment information
- Follow-up evaluations
- Adverse events
- Quality of life measures
- Establish investigator training program on:
- Device use
- Study procedures
- Data collection requirements
- Create comprehensive statistical analysis plan addressing:
- Primary endpoint analyses
- Secondary endpoint analyses
- Missing data handling
- Covariate analyses
- Develop monitoring procedures to ensure:
- Subject safety
- Protocol compliance
- Data quality and integrity
Key Considerations
Clinical testing
- Randomized controlled trial is recommended as the least burdensome means of collecting data
- Pilot study followed by pivotal study is recommended
- Study duration should be minimum 1 year follow-up
- Multi-center study recommended to assess consistency
- Primary effectiveness endpoints should be:
- Reduction in urine leakage via pad weight testing
- Reduction in incontinence episodes per day
- Primary safety endpoint based on adverse events incidence and severity
Human Factors
- Patient selection criteria must be clearly defined
- Inclusion/exclusion criteria must address confounding conditions
- Training program needed for investigators on device use
- Patient compliance and suitability must be assessed
Labelling
- Protocol should clearly describe all baseline tests and measurements
- Clear documentation of adverse events required
- Case report forms needed for each subject
Safety
- Risk analysis required describing increased risks and minimization methods
- Monitoring plan needed to ensure subject safety
- Documentation of all adverse events required
- Pregnancy risks must be considered
Other considerations
- Statistical analysis plan must be comprehensive and pre-specified
- Missing data should be minimized and documented
- Quality of life assessments recommended
- Sexual function impact should be assessed