Interstitial CystitisNCT00903435
Quantitative Studies of Urinary Bladder Sensation
An observational study of Interstitial Cystitis, run by Timothy Ness, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Quantitative Sensory Testing and Stimulus
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2009
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-healthy subjects will be recruited from Kirklin Clinic Urology Clinic and Pain Treatment Center. Healthy subjects will be recruited via advertisements.
Who may be able to join
- Must be able to read and speak English
- 19 years or older
- IC Diagnosis
Who cannot join
- Over 65 years old
- Pregnant
- Children younger than 19
- Significant cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.
Read the detailed description
To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.
- Conditions
- Interstitial Cystitis
- Being tested
- Quantitative Sensory Testing and Stimulus
- Keywords
- Cystitis, Urinary, Bladder
- Medical subject headings
- Cystitis, Interstitial, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Testing and StimulusOther
No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff.
Measured: One and a half to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Ness, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Ness, MD, University of Alabama at Birmingham
- Investigators
- Timothy Ness, M.D., Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903435
- Sponsor's protocol ID
- F060505003
- Other IDs
- 3R01DK051413-11S1
- Status last verified
- Nov 2011
- First submitted
- 23 Apr 2009
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Studies of Urinary Bladder Sensation
- ClinicalTrials.gov ID
- NCT00903435
- Acronym / sponsor ID
- F060505003
- Conditions
- Interstitial Cystitis
- Keywords
- Cystitis, Urinary, Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Timothy Ness, MDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 May 2009 (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.
The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.
Detailed description
To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-healthy subjects will be recruited from Kirklin Clinic Urology Clinic and Pain Treatment Center. Healthy subjects will be recruited via advertisements.
Key inclusion criteria (3 listed)
- Must be able to read and speak English
- 19 years or older
- IC Diagnosis
Key exclusion criteria (4 listed)
- Over 65 years old
- Pregnant
- Children younger than 19
- Significant cardiac disease
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 |
|---|---|---|
| Quantitative Sensory Testing and StimulusNo therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed. | Other | – |
Primary outcome
The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff.
Time frame: One and a half to two hours
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 1 Dec 2011.
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Investigation of PEMF Therapy for Female Patients With IC/BPS
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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.
Timothy Ness, M.D., Ph.D. principal investigator
University of Alabama at Birmingham
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 Interstitial Cystitis, run by Timothy Ness, MD 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 3 inclusion and 4 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 1 Dec 2011. 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?
The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff. (time frame: One and a half to two hours). 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 1 Dec 2011.