Sensory Sensitivity and Urinary Symptoms in the Female Population

NCT01978002 | Completed

• 1 other identifier: HUM00054279
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Urodynamics

  Sensation, desire to void, strong desire to void, and maximum cystometric capacity

  1 year

• 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

Study Arms (2)

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

Interventions

Pain sensitivity testing BEHAVIORAL

Group 1 (Clinic Patients); Group 2 (Community Sample)

Urodynamic testing BEHAVIORAL

Group 2 (Community Sample)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 18 years old

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1)