Painful Bladder SyndromeNCT00903643
Sensory Processing in Subjects With Painful Bladder Syndrome
An observational study of Painful Bladder Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Bladder Syndrome
- What is being tested?
- Physical examination
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with condition will be from Kirklin Clinic Urology Clinic and the Highlands Pain Treatment Clinic. Healthy subjects will be recruited via advertisements.
Who may be able to join
- NIDDK criteria for Painful Bladder Syndrome
- Age 19 years or older
- Must be able to read and speak English since testing materials are validated in English
Who cannot join
- PBS subjects must be independent of co-existing pain disorders or use of medications
- Uncontrolled hypertension or significant cardiopulmonary disease
- No chronic daily pain
- Older than 75 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Kirklin Clinic Urology Clinic
Birmingham, Alabama, 35294
About this study
The purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS.
Read the detailed description
Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. Further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.
- Conditions
- Painful Bladder Syndrome
- Being tested
- Physical examination
- Keywords
- Painful Bladder Syndrome, Urinary Bladder
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examinationOther
Physical examination and multiple questionnaires will be administered
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Other: Physical examination | |
| PBS subjects | Not described Receives: Other: Physical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on muscles and by applying a blood pressure cuff.
Measured: One and 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 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University Early Recognition Center
- Responsible party
- Sponsor
- Investigators
- Timothy Ness, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903643
- Sponsor's protocol ID
- F08047007
- Status last verified
- Jul 2014
- First submitted
- 14 May 2009
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Processing in Subjects With Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT00903643
- Acronym / sponsor ID
- F08047007
- Conditions
- Painful Bladder Syndrome
- Keywords
- Painful Bladder Syndrome, Urinary Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Washington University Early Recognition Center
- Study start
- May 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (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 if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS.
Detailed description
Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. Further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Physical examination |
| PBS subjects | – | Other: Physical examination |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with condition will be from Kirklin Clinic Urology Clinic and the Highlands Pain Treatment Clinic. Healthy subjects will be recruited via advertisements.
Key inclusion criteria (3 listed)
- NIDDK criteria for Painful Bladder Syndrome
- Age 19 years or older
- Must be able to read and speak English since testing materials are validated in English
Key exclusion criteria (4 listed)
- PBS subjects must be independent of co-existing pain disorders or use of medications
- Uncontrolled hypertension or significant cardiopulmonary disease
- No chronic daily pain
- Older than 75 years of age
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 |
|---|---|---|
| Physical examinationPhysical examination and multiple questionnaires will be administered | Other | Healthy subjects, PBS subjects |
Primary outcome
This study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on muscles and by applying a blood pressure cuff.
Time frame: One and 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 22 Jul 2014.
Related trials for Painful Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
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, MD, PhD 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 Painful Bladder Syndrome, run by University of Alabama at Birmingham 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 22 Jul 2014. 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?
This study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on muscles and by applying a blood pressure cuff. (time frame: One and 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 22 Jul 2014.