Bladder Pain and Discomfort Clinical Trial
| NCT number | NCT01978002 |
| Other study ID # | HUM00054279 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | October 25, 2013 |
| Last updated | April 11, 2016 |
| Start date | November 2011 |
| Verified date | April 2016 |
| Source | University of Michigan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - At least 18 years old Exclusion Criteria: - 1) Neurological disease or disorder affecting the bladder; 2) Previous augmentation cystoplasty or cystectomy; 3) Systemic autoimmune disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis; 4)History of pelvic cancer (colon, bladder, uterus, ovary); 5) Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc); 6) Current pregnancy. These exclusion criteria will be assessed at the time of the initial telephone interview. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urodynamics | Sensation, desire to void, strong desire to void, and maximum cystometric capacity | 1 year | No |
| Primary | Auditory Sensory Sensitivity | 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 | 1 year | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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