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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
Sponsor:
Information provided by (Responsible Party):
James Clemens, University of Michigan

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.


Condition or disease Intervention/treatment
Bladder Pain and Discomfort Urinary Urgency and Frequency Bothersome Symptoms Behavioral: Pain sensitivity testing Behavioral: Urodynamic testing

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Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : November 2011
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Urodynamics [ Time Frame: 1 year ]
    Sensation, desire to void, strong desire to void, and maximum cystometric capacity

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Group 1 will be women with a clinical diagnosis of IC/BPS or OAB, at least 18 years of age, who have had urodynamic testing performed within the preceding 6 months. All of these subjects will complete the questionnaires, mechanical sensitivity testing, and auditory sensitivity testing

Group 2 will be women recruited from the community sample, at least 18 years of age. All of these subjects will complete the questionnaires, mechanical sensitivity testing, and auditory sensitivity testing. Half of the subjects (n=30) will also undergo urodynamic testing to measure bladder sensitivity.

Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Responsible Party: James Clemens, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01978002    
Other Study ID Numbers: HUM00054279
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016