Clinical Trial: Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency

Brief Summary: The purpose of this study is to gain a better understanding of what causes urinary urgency in women by asking about different symptoms and measuring biomarker levels in their urine. Understanding the underlying causes of urinary urgency will allow us to develop treatment options to better take care of women with urinary urgency.

Detailed Summary: We propose to test the hypothesis that urinary urgency in women is caused by neurogenic inflammation that is manifested clinically as neuropathic pain and associated with the expression of neuroinflammatory biomarkers in the urine.
Sponsor: University of Pennsylvania

Current Primary Outcome: To determine the association between the severity of neuropathic pain and the severity of urinary symptoms in women with urinary urgency. [ Time Frame: 1 year ]

We propose a prospective cross-sectional study. We will recruit 137 women with urinary urgency and without incontinence or infection. All women will complete validated symptom questionnaires to measure neuropathic pain, urinary, bowel, sexual symptoms and quality of life. All patients will bring a first morning clean catch urine void to the office on ice within one week of completing the questionnaires. The specimen will be transported to the lab within 24 hours and stored at -80 degrees. Enzyme-linked immunosorbent assays (ELISA) will be used to determine expression of urinary creatinine and neuropeptides. The primary outcome will be the severity of urinary symptoms as measured by the Interstitial Cystitis Symptom Index.


Original Primary Outcome: Same as current

Current Secondary Outcome: The association between neuropathic pain and the expression of potential neural biomarkers in the urine of women with urinary urgency. [ Time Frame: 1 year ]

To determine the association between the severity of neuropathic pain and expression of urinary neurotrophic peptides in women with urgency. We hypothesize that in women with urinary urgency, increasing severity of neuropathic pain will be associated with increasing levels of urinary neurotrophic peptides NGF and BDNF. Nerve growth factor (NGF) and Brain-Derived Neurotrophic factor (BDNF) - NGF and BDNF are neurotrophic growth factors that are released in urine from different cell types in the bladder wall making urine a convenient sample for measurement of their levels. Activation of the myelinated A fiber and unmyelinated C fibers in the bladder wall can lead to an elevation in NGF and BDNF levels, sensitization of bladder afferent pathways and development of neurogenic inflammation in the urinary bladder [2,3].


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: August 27, 2013
Date Started: January 2013
Date Completion:
Last Updated: December 8, 2014
Last Verified: January 2013