JU INSIGHT Clinically Important Differences for Pain and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome

By: Alisa J. Stephens-Shields, PhD, University of Pennsylvania, Philadelphia; H. Henry Lai, MD, Washington University, St Louis, Missouri; J. Richard Landis, PhD, University of Pennsylvania, Philadelphia; Karl Kreder, MD, MBA, University of Iowa, Iowa City; Larissa V. Rodriguez, MD, Weill Cornell Medicine, New York, New York; Bruce D. Naliboff, PhD, University of California, Los Angeles; Niloofar Afari, PhD, University of California, San Diego; Siobhan Sutcliffe, PhD, ScM, MHS, Washington University, St Louis, Missouri; Robert Moldwin, MD, Zucker School of Medicine at Hofstra-Northwell, Lake Success, New York; James W. Griffith, PhD, Northwestern University, Chicago, Illinois; J. Quentin Clemens, MD, University of Michigan, Ann Arbor; Catherine S. Bradley, MD, MSCE, University of Iowa, Iowa City; Susan Quallich, PhD, University of Michigan, Ann Arbor; Priyanka Gupta, MD, University of Michigan, Ann Arbor; Steven E. Harte, PhD, University of Michigan, Ann Arbor; John T. Farrar, MD, PhD, University of Pennsylvania, Philadelphia | Posted on: 27 Jun 2023

Stephens-Shields AJ, Lai HH, Landis JR, et al. Clinically important differences for pain and urinary symptoms in urological chronic pelvic pain syndrome: a MAPP network study. J Urol. 2023;209(6):1132-1140.

Study Need and Importance

Phenotypic heterogeneity in individuals with interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively termed urological chronic pelvic pain syndromes, has led to challenges in selecting primary end points in therapeutic trials. Clinically important differences (CIDs) are defined as magnitudes of change in symptoms that patients perceive as meaningful. Using longitudinal data from the MAPP (Multidisciplinary Approach to the Study of Chronic Pelvic Pain) Research Network, we determined CIDs for the pelvic pain severity (PPS) index and the urinary symptom severity (USS) index, 2 novel symptom measures. We derive CIDs using absolute and percent change and evaluate differences in CIDs across phenotypic subgroups, including sex-diagnosis, presence or absence of Hunner lesions, and widespread or localized pain.

What We Found

Among all participants an absolute reduction of 6.8 in the 28-point PPS and 3.5 in the 25-point USS was meaningful based on regression methodology; this increased to a reduction of 8.7 in PPS among participants with moderate to severe pelvic pain at baseline. Participants with Hunner lesions or a likely neuropathic phenotype required larger absolute decreases in PPS to feel improved (see Figure). Females required larger reductions in USS than males to feel improved, regardless of diagnosis. Percent change CID ranged from 30% to 50% and was more consistent across phenotypic subgroups than absolute change.

Figure. Estimates of absolute (left) and percent (right) clinically important differences for pelvic pain severity (PPS). Marker size is proportional to sample size; whiskers represent pointwise 95% confidence intervals. CID indicates clinically important differences; CP/CPPS, chronic prostatitis/chronic pelvic pain syndrome; IC/BPS, interstitial cystitis/bladder pain syndrome; N, no; USS, urinary symptom severity; Y, yes.

Limitations

This study used a single Global Responses Assessment (GRA) as the anchor to determine CIDs for pain and urinary symptoms, with lower correlation between the GRA and USS than the GRA and PPS.

Interpretation for Patient Care

CIDs in pain and urinary measures differ according to phenotypic characteristics. Percent change in improvement or worsening of symptoms, which was more consistent across phenotypic subgroups, is a viable approach for assessing outcomes in clinical management and future therapeutic trials.