Overactive BladderNCT01933074
Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency
An observational study of Overactive Bladder, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urogynecology clinic
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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Trial locations and contacts
1 site in 1 country.
United States1 site
Pelvic and Sexual Health Insitute
Philadelphia, Pennsylvania, 19102
About this study
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.
Read the 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.
- Conditions
- Overactive Bladder
- Keywords
- Urinary Urgency
- Medical subject headings
- Urinary Bladder, Overactive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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].
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uduak Umoh-Andy, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933074
- Sponsor's protocol ID
- 817047
- Status last verified
- Jan 2013
- First submitted
- 27 Aug 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency
- ClinicalTrials.gov ID
- NCT01933074
- Acronym / sponsor ID
- 817047
- Conditions
- Overactive Bladder
- Keywords
- Urinary Urgency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urogynecology clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uduak Umoh-Andy, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.