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Sensory Sensitivity and Urinary Symptoms in the Female Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01978002
Enrollment
26
Registered
2013-11-07
Start date
2011-11-30
Completion date
Unknown
Last updated
2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Pain and Discomfort, Bothersome Symptoms, Urinary Urgency and Frequency

Brief 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.

Interventions

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urodynamics1 yearSensation, desire to void, strong desire to void, and maximum cystometric capacity
Auditory Sensory Sensitivity1 yearSensitivity 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026