There is a need to develop a self-report measure that reliably identifies moderate to severe bladder pain syndrome (BPS) patients for inclusion into clinical trials to assess the efficacy of new BPS treatments.
To develop and validate a patient-reported symptom-based instrument, the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS), for clinical trial eligibility of BPS patients.
Design, setting, and participants
Stage 1: Qualitative concept elicitation (CE) interviews were conducted with BPS patients in France (n
In addition to the BPIC-SS, the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, the Interstitial Cystitis Symptom Index, a Clinician Global Impression of Severity, and a Patient Global Impression of Change were included in the observational study.
Results and limitations
In CE, reported symptoms were bladder pain, persistent urge to urinate, and high urinary frequency. In CD, 13 items were deleted, and 15 were retained. Based on validation analyses, qualitative findings, and clinical relevance, the instrument was reduced to eight items that had strong sensitivity (0.72) and specificity (0.86) with a cut score ≥19 to determine clinical trial inclusion. Psychometric properties were strong.
The BPIC-SS is a reliable, valid, and appropriate questionnaire to select BPS/interstitial cystitis patients for clinical trials.
Keywords: Bladder pain syndrome, Painful bladder syndrome, Interstitial cystitis, Screener, Qualitative research, Cut score, Receiver operating characteristic (ROC) curve, Questionnaire.
a Mapi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, United Kingdom
b Hofstra University School of Medicine, Pelvic Pain Treatment Center, The Arthur Smith Institute for Urology, North Shore-LIJ Healthcare System, New Hyde Park, NY 11040, USA
c University of Copenhagen, Copenhagen, Denmark
d Department of Urology, Herlev Hospital, Herlev, Denmark
e Department of Immunology and Internal Medicine, Erasmus MC, Rotterdam, The Netherlands
f Mapi Values, Lyon, France
g Pfizer Ltd, Walton Oaks, Walton on the Hill, Tadworth, Surrey KT20 7NS, United Kingdom
© 2011 European Association of Urology, Published by Elsevier B.V.