University of Wisconsin–Madison

Patient Related Outcomes for Interstitial Cystitis/Bladder Pain Syndrome Recommendations for Clinical Trials and General Urology Practice

Byron Hayes 1, Mary Namugosa 2, Robert J Evans 2, Sakineh Hajebrahimi 3, Dick Janssen 4, Claudia King 5, Sanjay Pandey 6, J Curtis Nickel 7

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Abstract

Introduction: The goal of this committee of the Interstitial Cystitis/Bladder Pain (IC/BPS) Consensus Group was to address the use of patient related outcomes (PROs) in IC/BPS.

Methods: Priority areas of concern and related PICO (Population, Intervention, Comparison, Outcome) questions were addressed based on literature review, committee discussion and consensus group feedback. Consensus recommendations were developed regarding PROs and PRO Measures (PROMs) for the critical PICO questions.

Results: PICO questions addressed 4 critical areas of concern: PROs, clinical trial primary endpoints, secondary endpoint PROMs and questionnaires for general practice management. The committee made 12 recommendations regarding outcomes in IC/BPS research and clinical practice.

Discussion: The most important recommendation was the unmet need to develop and validate a better IC/BPS specific PRO, based on unbiased patient qualitative research methodology. At the present time, the Numerical Rating/VAS pain scales, voiding diaries and global response assessment are recommended for primary endpoint outcomes in clinical trials. The suggested composite IC/BPS specific PROM is the Genito Urinary Pain Index (GUPI) while the Interstitial Cystitis Symptom Index/Problem Index can be used for trial comparisons. If appropriate, generic PROMs that describe and measure pain, quality of life, sexual, and psychosocial parameters are suggested. Until a validated PRO is developed, the NIH GUPI or the Pain Urinary Frequency (PUF) questionnaire provides reasonable clinical evaluation of patients in standard urology practice.

Conclusion: PROMs are currently available for use in clinical trials and general practice, but more research is required to create better IC/BPS PRO-based outcome measures.

Keywords: Interstitial cystitis; bladder pain syndrome; clinical trials; outcomes; patient related outcomes.