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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933074
• Other study ID #: 817047
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: December 8, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria: Age > 18, urinary urgency (at least mild bother on a single item Urgency Scale), and negative urine dipstick on clean catch.

Exclusion Criteria:: Urinary incontinence (greater than mild on the Incontinence Severity Index), recent (<6week) urinary tract infection, active or recent(<3month) nephrolithiasis, prior diagnosis of congenital urinary tract abnormality, known neurological disorder (multiple sclerosis, Parkinson's, spina bifid, spinal cord injury), recent pregnancy < 3 months, prior sacral nerve stimulation or Botox injection.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurogenic Inflammation
• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	Pelvic and Sexual Health Insitute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the association between the severity of neuropathic pain and the severity of urinary symptoms in women with urinary urgency.	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.	1 year	No
Secondary	The association between neuropathic pain and the expression of potential neural biomarkers in the urine of women with urinary urgency.	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].	1 year	No