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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Pelvic and Sexual Health Insitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Urogynecology clinic

Description

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

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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.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Uduak Umoh-Andy, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Urinary Urgency
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Urinary Bladder, Overactive; Inflammation; Neurogenic Inflammation
• Other Study ID Numbers: 817047