Widespread Pain Phenotypes Impact Treatment Efficacy Results in Randomized Clinical Trials for Interstitial Cystitis/Bladder Pain Syndrome: A MAPP Network Study.

Clinical trials of pain are notoriously difficult and inefficient in demonstrating efficacy even for known efficacious treatments. Determining the appropriate pain phenotype to study can be problematic. Recent work has identified the extend of widespread pain as an important factor in the likelihood of response to therapy, but has not been tested in clinical trials. Using data from three previously published negative studies of the treatment of interstitial cystitis/ bladder pain with data on the extent of widespread pain, we examined the response of patients to different therapies base on the amount of pain beyond the pelvis. Participants with predominately local but not widespread pain responded to therapy targeting local symptoms. Participants with widespread and local pain responded to therapy targeting widespread pain. Differentiating patients with and without widespread pain phenotypes may be a key feature of designing future pain clinical trials to demonstrate treatments that are effective versus not.

Déclaration de conflit d'intérêts

John T Farrar reports over the past 3 years funding from NIH-NCATS – UL1 Grant (Co-I), NIH-NIDDK - U01 Grants (CoI), from NIH-NINDS - U24 Grant (PI), and two FDA-BAA Contracts; and compensation for serving on two NIH DSMBs. Has served on advisory boards as a consultant on clinical trial methods from Vertex and Lilly. Kenneth T Locke reports no relevant conflicts J Quentin Clemens reports no relevant conflicts James W. Griffith reports no relevant conflicts Steven E Harte reports no relevant conflicts Ziya Kirkali reports no relevant conflicts Karl J Kreder reports no relevant conflicts John N Krieger reports no relevant conflicts H Henry Lai reports no relevant conflicts Robert Moldwin reports no relevant conflicts Chris Mullins reports no relevant conflicts Bruce D Naliboff reports no relevant conflicts Michael A Pontari reports being a site for a clinical trial with Lipella Pharmaceuticals Inc. Larissa V Rodriguez reports no relevant conflicts Anthony J Schaeffer reports no relevant conflicts Andrew Schrepf reports no relevant conflicts Alisa J Stephens-Shields reports no relevant conflicts Siobhan Sutcliffe reports no relevant conflicts Bayley J Taple reports no relevant conflicts David A Williams reports consultant relationship with Swing Therapeutics, Inc., and Community Health Focus, Inc. J. Richard Landis reports no relevant conflicts