1508 Tanezumab Reduces Pain and Urgency in Interstitial Cystitis: Results of a Phase 2 Trial

Abstract

METHODS: A total of 599 women with diagnoses of interstitial cystitis/painful bladder syndrome (IC/PBS) and/or endometriosis, vulvodynia, or overactive bladder (OAB) were recruited from the clinical practices of urologists (nϭ8) and gynecologists (nϭ15) across the United States and interviewed by telephone. Subjects who reported pain, pressure or discomfort in the lower abdomen or pelvic area were asked to describe exactly what these sensations felt like. Responses were recorded verbatim, coded and analyzed. Network analysis methods were employed to assess the associations among multiple descriptors simultaneously to determine the extent of heterogeneity in patient experience within and across diagnoses. The analysis was restricted to the 473 women with who provided codable comments (IC/PBSϭ215, endometriosisϭ49, vulvodyniaϭ34, OABϭ68, IC plus otherϭ92 and Mixed, not ICϭ15).RESULTS: Most diagnoses were associated with at least one clear and interpretable symptom, as shown in Figure 1. For example, endometriosis was associated with cramping, vulvodynia with burning and itching, OAB with accidents and unproductive urination, and IC/ PBS with urgency, pain before and after urination, pain all or much of the time, and pain located in the urinary tract or bladder. Being diagnosed with multiple conditions was associated with a range of symptoms that was difficult to interpret. Pain, pressure, bloating, and discomfort were associated with all of the conditions and did not associate closely with any one of them. Burning was associated with being diagnosed with IC/PBS and another condition, possibly due to a co-occurrence of IC/PBS and vulvodynia in some patients.CONCLUSIONS: While some conditions were associated with symptoms that were distinctive, many common symptoms that women describe were associated with many of the conditions. This may make it difficult to assign a clear diagnosis.

Nerve growth factor in bladder dysfunction: Contributing factor, biomarker, and therapeutic target

“…After 6 weeks, a single 250 µg/kg i.v. injection of tanezumab reduced average self‐reported daily pain score and urgency episode frequency, but had no effect on micturition frequency or mean voiding volume 150. However, currently, further studies in IC/PBS have been suspended in conjunction with serious adverse events observed with tanezumab in trials with ostheoarthritis patients (http://clinicaltrials.gov/).…”