Sensory Sensitivity and Urinary Symptoms in the Female Population
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|ClinicalTrials.gov Identifier: NCT01978002|
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : April 13, 2016
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.
|Condition or disease||Intervention/treatment|
|Bladder Pain and Discomfort Urinary Urgency and Frequency Bothersome Symptoms||Behavioral: Pain sensitivity testing Behavioral: Urodynamic testing|
|Study Type :||Observational|
|Estimated Enrollment :||26 participants|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||August 2014|
Group 1 (Clinic Patients)
Women who have documented urinary status from surveys completed.
Behavioral: Pain sensitivity testing
Group 2 (Community Sample)
Women who have a clinical diagnosis of IC/BPS or OAB, and who have undergone urodynamic testing within the preceding 6 months as part of their routine clinical care.
Behavioral: Pain sensitivity testing
Behavioral: Urodynamic testing
- Urodynamics [ Time Frame: 1 year ]Sensation, desire to void, strong desire to void, and maximum cystometric capacity
- Auditory Sensory Sensitivity [ Time Frame: 1 year ]Sensitivity for loudness threshold will be performed using pure tone acoustic stimuli at an octave frequency of 2000 Hz and signal range from 40 to 100 dB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978002
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|