FibromyalgiaMAPP-ControlNCT01098292
Observational Study of Control Participants for the MAPP Research Network
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by University of Pennsylvania at 8 sites in United States.
Trial summary
The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Irritable Bowel Syndrome, Fatigue Syndrome, Chronic
- How many people
- 615 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2009to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Trans-MAPP Control Study population will include adult participants, at least 18 years of age, with no urological chronic pelvic pain syndromes. These participants will fall into two categories: Healthy Controls and Positive Controls.
Who may be able to join
- Participants are eligible for the Trans-MAPP Control Protocol if they meet the following general and gender-specific criteria listed below:
- Participant has signed and dated the appropriate Informed Consent document.
- Agreed to participate in Trans-MAPP Control Study procedures;
- Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.
- Participant reports no chronic pain in the pelvic or bladder region, and reports chronic pain in no more than one other body region.
- Participant reports no urological symptoms that have been evaluated, but are still present.
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- 1. Participant meets the validated criteria for one or more of the following conditions
- Fibromyalgia (FM)
- Irritable bowel syndrome (IBS)
- Chronic fatigue syndrome (CFS)
Who cannot join
- Individuals will not be eligible for enrollment in the Trans-MAPP Control Study if they meet any of the criteria:
- Participant has an on-going symptomatic urethral stricture.
- Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
- Participant has a history of cystitis caused by tuberculosis or radiation therapy or Cytoxan/cyclophosphamide therapy.
- Participant has augmentation cystoplasty or cystectomy.
- Participant has a systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).
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- Participant has a history of cancer (with the exception of skin cancer).
- Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
- Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
- Male participant diagnosed with unilateral orchialgia, without pelvic symptoms.
- Male participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, or prostate cryosurgery or laser procedure.
- 1) Female participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48106
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Northwestern University
Chicago, Illinois, 60611
University of Iowa
Iowa City, Iowa, 52242
University of California, Los Angeles
Los Angeles, California, 90073
University of Washington
Seattle, Washington, 98101
Washington University
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94304
About this study
Official title: Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study
The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.
Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as a reference/control group for the Trans-MAPP Epidemiology \& Phenotyping (EP) Study.
As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP. The MAPP Control Study is an observational study that will enroll participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask questions and gather information about the health and life of the participants for research purposes. The investigators hope that this study will lead to improvement in the treatment of IC and CP.
Read the detailed description
Trans-MAPP Control participants will only need to complete one study visit to collect baseline data and biospecimens. Potential participants will be scheduled for an eligibility screening session. Following screening, potentially eligible participants will complete a baseline phenotyping session, and biospecimen collections, which together are expected to take approximately 2.5 hours to complete. Participants will be provided with breaks as needed during the clinic visit.
- Keywords
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Interstitial Cystitis, Chronic Prostatitis, Urological Chronic Pelvic Pain, Painful Bladder Syndrome
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Fatigue Syndrome, Chronic, Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy Control participants do not suffer from any Urological Chronic Pelvic Pain Syndromes or from the following conditions: Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome | |
| Positive Control | Positive Control participants do not suffer from any Urological Pelvic Pain Syndromes like Interstitial Cystitis and/or Chronic Prostatitis. However Positive Controls have a history of one of the following conditions: Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline outcome measures
Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP Control Study. These measures can be classified into a number of primary domains as described below.
- General Measures of Sociodemographics, Health, and Quality of Life
- UCPPS Symptoms Measures
- Non-urological Symptom Measures
- Trait-like Personal Factors
- Biological Specimens
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- J. Quentin Clemens, MD, Study chair, University of MichiganChristopher Mullens, PhD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098292
- Sponsor's protocol ID
- 810668
- Acronym
- MAPP-Control
- Status last verified
- May 2013
- First submitted
- 1 Apr 2010
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study
- ClinicalTrials.gov ID
- NCT01098292
- Acronym / sponsor ID
- MAPP-Control / 810668
- Keywords
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Interstitial Cystitis, Chronic Prostatitis, Urological Chronic Pelvic Pain, Painful Bladder Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Apr 2010 (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 Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.
Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as a reference/control group for the Trans-MAPP Epidemiology \& Phenotyping (EP) Study.
As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP. The MAPP Control Study is an observational study that will enroll participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask questions and gather information about the health and life of the participants for research purposes. The investigators hope that this study will lead to improvement in the treatment of IC and CP.
Detailed description
Trans-MAPP Control participants will only need to complete one study visit to collect baseline data and biospecimens. Potential participants will be scheduled for an eligibility screening session. Following screening, potentially eligible participants will complete a baseline phenotyping session, and biospecimen collections, which together are expected to take approximately 2.5 hours to complete. Participants will be provided with breaks as needed during the clinic visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Healthy Control participants do not suffer from any Urological Chronic Pelvic Pain Syndromes or from the following conditions: Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome |
| Positive Control | – | –Positive Control participants do not suffer from any Urological Pelvic Pain Syndromes like Interstitial Cystitis and/or Chronic Prostatitis. However Positive Controls have a history of one of the following conditions: Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Trans-MAPP Control Study population will include adult participants, at least 18 years of age, with no urological chronic pelvic pain syndromes. These participants will fall into two categories: Healthy Controls and Positive Controls.
Key inclusion criteria (10 listed)
- Participants are eligible for the Trans-MAPP Control Protocol if they meet the following general and gender-specific criteria listed below:
- Participant has signed and dated the appropriate Informed Consent document.
- Agreed to participate in Trans-MAPP Control Study procedures;
- Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.
- Participant reports no chronic pain in the pelvic or bladder region, and reports chronic pain in no more than one other body region.
Key exclusion criteria (12 listed)
- Individuals will not be eligible for enrollment in the Trans-MAPP Control Study if they meet any of the criteria:
- Participant has an on-going symptomatic urethral stricture.
- Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
- Participant has a history of cystitis caused by tuberculosis or radiation therapy or Cytoxan/cyclophosphamide therapy.
- Participant has augmentation cystoplasty or cystectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline outcome measures
Time frame: Baseline
Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP Control Study. These measures can be classified into a number of primary domains as described below. 1. General Measures of Sociodemographics, Health, and Quality of Life 2. UCPPS Symptoms Measures 3. Non-urological Symptom Measures 4. Trait-like Personal Factors 5. Biological Specimens
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 10 Dec 2014.
- MAPP Research Network WebsiteLink provided by the sponsor.
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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.
J. Quentin Clemens, MD study chair
University of Michigan
Christopher Mullens, PhD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by University of Pennsylvania at 8 sites 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 10 inclusion and 12 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Baseline outcome measures (time frame: Baseline). 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 10 Dec 2014.