Bladder Pain and DiscomfortNCT01978002
Sensory Sensitivity and Urinary Symptoms in the Female Population
An observational study of Bladder Pain and Discomfort and Urinary Urgency and Frequency, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Pain and Discomfort, Urinary Urgency and Frequency, Bothersome Symptoms
- What is being tested?
- Pain sensitivity testing and Urodynamic testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- At least 18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Pain sensitivity testing, Urodynamic testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain sensitivity testingBehavioural
Urodynamic testingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Clinic Patients) | Women who have documented urinary status from surveys completed. Receives: 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. Receives: Behavioral: Pain sensitivity testing; Behavioral: Urodynamic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamics
Sensation, desire to void, strong desire to void, and maximum cystometric capacity
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2011
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Pain and DiscomfortStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Clemens, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978002
- Sponsor's protocol ID
- HUM00054279
- Status last verified
- Apr 2016
- First submitted
- 25 Oct 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Sensitivity and Urinary Symptoms in the Female Population
- ClinicalTrials.gov ID
- NCT01978002
- Acronym / sponsor ID
- HUM00054279
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Clinic Patients) | – | Behavioral: Pain sensitivity testingWomen who have documented urinary status from surveys completed. |
| Group 2 (Community Sample) | – | Behavioral: Pain sensitivity testing, Behavioral: Urodynamic testingWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- At least 18 years old
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain sensitivity testing | Behavioural | Group 1 (Clinic Patients), Group 2 (Community Sample) |
| Urodynamic testing | Behavioural | Group 2 (Community Sample) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Pain and Discomfort and Urinary Urgency and Frequency, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urodynamics (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.