Interstitial CystitisNCT02898220
Trans-MAPP II Study of Urologic Chronic Pelvin Pain
An observational study of Interstitial Cystitis and Chronic Prostatitis, run by University of Pennsylvania at 6 sites in United States.
Trial summary
The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the study of Interstitial Cystitis (IC)/ Bladder… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis, Chronic Prostatitis
- How many people
- 72 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2016to Jun 2022
- 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 II control study will recruit healthy controls (male and female) over a two year period.
Who may be able to join
- Participant has signed and dated the appropriate Informed Consent document.
- Agreed to participate in ALL required study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
- Gave permission for use of DNA for genetics studies.
- Gender recorded in Participant Registration module.
- Participant is at least 18 years of age.
- Participant is able to speak, read, and understand English.
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- Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale (SYM-Q, Question #1).
- Participant reports no chronic pain in the pelvic or bladder region, and reports no chronic pain in any other body region.
- Participant reports no urological symptoms that have been evaluated, but are still present.
Who cannot join
- 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, radiation therapy or Cytoxan/cyclophosphamide therapy.
- Participant has augmentation cystoplasty or cystectomy.
- Participant has an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).
- Participant has a history of cancer (with the exception of skin cancer).
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- 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.
- Participant has had definitive treatment for acute epididymitis, urethritis, vaginitis.
- Participant has history of unevaluated hematuria, this will require the evaluation of a study physician to determine if this has been appropriately evaluated.
- Participant has had a cystoscopy with hydrodistention or kenalog injection.
- Diagnosis of unilateral orchalgia, without pelvic symptoms.
- History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.
- A prostate biopsy or transurethral resection of the prostate (TURP) within the last three months.
- Participant has a positive Urine pregnancy test.
- Specimen Exclusion Criteria (Males and Females):
- Participant has a positive dipsticParticipant has a positive urine culture.
- Fatigue Symptom Eligibility Criteria:
- Participant, for at least 3 months in the past year, has persistent fatigue not relieved with rest.
- Participant, for at least 3 months in the past year, has extreme fatigue following exercise or mild exertion.
- Participant, for at least 3 months in the past year, has impaired memory, concentration or attention.
- A clean-catch midstream urine specimen (VB2) will be obtained from all male and female participants during the initial and 6 month study visits, so that a urine dipstick analysis can be done for all participants, and a urine pregnancy test can be conducted for females of child bearing age excluding those who are post-menopausal and those with a history of hysterectomy.
- If participant has an abnormal dipstick urinalysis indicating abnormal levels of nitrites and/or occult blood, that in the opinion of the Principal Investigator warrants exclusion, participant will be ineligible for study participation at the initial visit and withdrawn from study participation. A positive dipstick at the 6 Month visit will also result in the participant being withdrawn.
- If participant has had a positive urine culture in the past 6 weeks, or currently has a midstream urine culture (VB2) (>100,000 CFU/ml), with a single uropathogen, the participant will be ineligible for the study at the initial visit, treated and withdrawn from study participation. A positive dipstick at the 6 Month visit will also result in the participant being treated and withdrawn. (Must be documented on Urine Culture Result - UCR form). We will keep all specimens and data collected from both eligible and in-eligible participants unless participant request that his/her data be destroyed, and not utilized for the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48106
Northwestern University
Chicago, Illinois, 60611
University of Iowa
Iowa City, Iowa, 52242
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
University of Washington, Seattle
Seattle, Washington, 98195
Washington University, St. Louis
St Louis, Missouri, 63119
About this study
Official title: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Control Study Protocol
The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Patients with IC or CP are being recruited for a new study called the "Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will recruit Control Participants to better understand the symptoms of individuals with some form of IC or CP. 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 and the investigators hope that this study will lead to improvement in the treatment of IC and CP.
Read the detailed description
Urological Chronic Pelvic Pain Syndromes (UCPPS) are characterized by pelvic pain with concurrent urinary symptoms. Broadly, UCPPS comprise Interstitial Cystitis/Painful Bladder SyndromeBladder Pain Syndrome (IC/BPS) in men and women, and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in men. IC is a debilitating bladder disorder characterized by urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.1 BPS as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology."2 BPS is a clinical description of disease based on the patient's symptoms, and does not depend on urodynamic or cystoscopic findings. These symptoms may be related to IC, although diagnostic criteria are still lacking for this entity, and the relationship between BPS and IC is not clear. After the initiation phase for the MAPP SPS Study, it became clear that many of the hypotheses being proposed required well-characterized healthy "normal" controls that lack urologic pain as well as other study related symptoms/conditions. This second phase is enriched with pre-defined subgroups and a longer follow-up period which will allow further investigation of clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
- Conditions
- Interstitial Cystitis, Chronic Prostatitis
- Medical subject headings
- Cystitis, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity Score
The outcome measures are the same scores which will be used to compare normal The scores for pain severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS)
Measured: 6 months
Urinary Severity Score
The outcome measures are the same scores which will be used to compare normal The scores for urinary severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2020
- Study completionJun 2022
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.
- 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
- 72 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
- Richard Landis, Ph.D., Study director, University of PennsylvaniaChristopher Mullins, Ph.D, Study director, NIDDK, NIHJ. Quentin Clemens, MD, MSCI, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898220
- Sponsor's protocol ID
- 825428
- Other IDs
- U01DK082316
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2016
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Plans are still to be finalized
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-MAPP Study of Urologic Chronic Pelvic Pain: Control Study Protocol
- ClinicalTrials.gov ID
- NCT02898220
- Acronym / sponsor ID
- 825428
- Conditions
- Interstitial Cystitis, Chronic Prostatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 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
- Sep 2016
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 13 Sep 2016 (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 Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Patients with IC or CP are being recruited for a new study called the "Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will recruit Control Participants to better understand the symptoms of individuals with some form of IC or CP. 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 and the investigators hope that this study will lead to improvement in the treatment of IC and CP.
Detailed description
Urological Chronic Pelvic Pain Syndromes (UCPPS) are characterized by pelvic pain with concurrent urinary symptoms. Broadly, UCPPS comprise Interstitial Cystitis/Painful Bladder SyndromeBladder Pain Syndrome (IC/BPS) in men and women, and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in men. IC is a debilitating bladder disorder characterized by urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.1 BPS as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology."2 BPS is a clinical description of disease based on the patient's symptoms, and does not depend on urodynamic or cystoscopic findings. These symptoms may be related to IC, although diagnostic criteria are still lacking for this entity, and the relationship between BPS and IC is not clear. After the initiation phase for the MAPP SPS Study, it became clear that many of the hypotheses being proposed required well-characterized healthy "normal" controls that lack urologic pain as well as other study related symptoms/conditions. This second phase is enriched with pre-defined subgroups and a longer follow-up period which will allow further investigation of clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Trans-MAPP II control study will recruit healthy controls (male and female) over a two year period.
Key inclusion criteria (9 listed)
- Participant has signed and dated the appropriate Informed Consent document.
- Agreed to participate in ALL required study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
- Gave permission for use of DNA for genetics studies.
- Gender recorded in Participant Registration module.
- Participant is at least 18 years of age.
Key exclusion criteria (24 listed)
- 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, radiation therapy or Cytoxan/cyclophosphamide therapy.
- Participant has augmentation cystoplasty or cystectomy.
- Participant has an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).
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
Pain Severity Score
Time frame: 6 months
The outcome measures are the same scores which will be used to compare normal The scores for pain severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS)
Urinary Severity Score
Time frame: 6 months
The outcome measures are the same scores which will be used to compare normal The scores for urinary severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS
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 5 Aug 2022.
- Individual participant dataSharing planned: Yes. Plans are still to be finalized
Related trials for Interstitial Cystitis
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Migraine Medication Effects on Urinary Symptoms
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Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
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Recruiting
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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.
Richard Landis, Ph.D. study director
University of Pennsylvania
Christopher Mullins, Ph.D study director
NIDDK, NIH
J. Quentin Clemens, MD, MSCI study director
University of Michigan
6 sites 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 and Chronic Prostatitis, run by University of Pennsylvania at 6 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 9 inclusion and 24 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Pain Severity Score (time frame: 6 months). 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 5 Aug 2022.