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NCT01978002 · ClinicalTrials.gov registry record
Sensory Sensitivity and Urinary Symptoms in the Female Population
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 26
- Enrollment target
NCT01978002: Completed study, sponsored by University of Michigan.
NCT01978002 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01978002 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study Summary
Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome symptoms seen frequently in the general population. Clinical diagnostic terms used to describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS), chronic prostatitis, and overactive bladder (OAB), but there is tremendous overlap between these entities, and the distinction between them is based more on eminence than evidence. Pain and/or sensory sensitivity has been suspected to play a role in the pathogenesis of both bladder pain and urinary urgency/frequency. However, no previous studies have investigated whether entities such as IC/BPS and OAB might merely represent different points in a continuum of bladder sensory sensitivity. Moreover, we know of no studies that have directly compared sensory sensitivity in the bladder to global (i.e. CNS-mediated) sensory sensitivity. In the study, a team of investigators with complementary expertise will perform a population-based study assessing bladder and overall sensory sensitivity, in a cohort of women representative of the population with respect to the entire continuum of bladder pain (from none to severe), and symptoms of urgency/frequency. These individuals will undergo urodynamics to measure sensory sensitivity in the bladder, as well as pressure pain and auditory loudness thresholds. The Specific Aims are to demonstrate: 1) sensory sensitivity in the bladder is related to sensory sensitivity elsewhere in the body, suggesting a CNS-driven mechanism, and 2) individuals in the population with greater global sensory sensitivity will display: a) more bladder pain, b) more urgency/frequency, and c) other symptoms of centrally-mediated pain states, such as pain in regions other than the bladder, fatigue, and insomnia.
Primary Outcome
Sensation, desire to void, strong desire to void, and maximum cystometric capacity
Interventions
- BEHAVIORAL Pain sensitivity testing
- BEHAVIORAL Urodynamic testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-11 |
What the finished NCT01978002 record still lists
NCT01978002 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Pain sensitivity testing is the first listed.
NCT01978002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01978002 about?
NCT01978002 is a clinical study titled "Sensory Sensitivity and Urinary Symptoms in the Female Population". Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome symptoms seen frequently in the general population. Clinical diagnostic terms used to describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS), chronic prostatitis, and overactive bla...
What is the current status of trial NCT01978002?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2011-11.
What interventions are being tested in trial NCT01978002?
The interventions under investigation include: Pain sensitivity testing (BEHAVIORAL), Urodynamic testing (BEHAVIORAL).
Who is sponsoring clinical trial NCT01978002?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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