Pelvic Floor Disorders Registry: Study Design and Outcome Measures

Area of Science:

• Urogynecology
• Medical Device Research
• Clinical Data Management

Background:

• Pelvic organ prolapse (POP) affects a significant percentage of adult women, often necessitating surgical intervention.
• Current surgical repair methods, including mesh augmentation, lack comprehensive comparative effectiveness and safety data.
• There is a need for standardized data collection to guide best practices in POP treatment.

Purpose of the Study:

• To establish the Pelvic Floor Disorders Registry (PFDR) for quality improvement and research in POP treatments.
• To create a resource for surgical benchmarking, outcomes data, and regulatory studies.
• To enhance the quality of care for women with pelvic floor disorders.

Main Methods:

• Prospective collection of provider-reported clinical data and patient-reported outcomes.
• Data gathered at baseline and up to 3 years post-treatment for surgical and non-surgical interventions.
• Standardized data elements, including success measures, adverse events, and surgeon characteristics, defined collaboratively.

Main Results:

• The PFDR will facilitate the collection of high-quality, standardized patient-level data.
• Data will enable evaluation of short- and longer-term treatment outcomes and complications.
• The registry will identify factors associated with treatment success and failure.

Conclusions:

• The PFDR provides a platform for robust research into pelvic floor disorder treatments.
• Findings will contribute to improving the quality of care for women with POP.
• Standardized data collection is crucial for advancing urogynecological surgical practices.