Interstitial CystitisMAPP II SPSNCT02514265
Trans-MAPP Symptom Patterns Study (SPS)
An observational study of Interstitial Cystitis and Chronic Prostatitis, run by University of Pennsylvania at 6 sites in United States.
Trial summary
This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors… 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
- 640 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jul 2015to Jun 2020
- 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 SPS study will include adults 18 years and older with urological pelvic pain syndromes. Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of Pelvis pain only.
Who may be able to join
- Patients are eligible for the SPS if they meet the following criteria:
- Participant has signed and dated the appropriate Informed Consent document.
- Agreed to participate in ALL required Symptoms Patterns Study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
- Gave permission for use of DNA for genetics studies.
- Participant is at least 18 years of age.
- Participant is able to speak, read, and understand English.
Show all 10Show fewer
- In the past 3 months participant has had a feeling of pain, pressure, or discomfort in the lower abdomen or pelvic area -- that is, the part of the body that is above the participant's legs and below the belly button.
- These symptoms have been present for the majority of the time during the most recent 3 months.
- Participant reports a response of at least 1 on the pain, pressure or discomfort scale for UCPPS symptoms during the past 2 weeks.
- Participant has received a clinical diagnosis of either or both IC/BPS or CP/CPPS (per AUA guidelines) or a clinician familiar with UCPPS criteria confirms participant meets UCPPS evaluation criteria per-protocol.
Who cannot join
- Any patient meeting any one of the following criteria will not be eligible for enrollment in the Symptom Patterns Study. However, participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed. It will be recorded in the follow-up data if a patient has developed any of the exclusion 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, 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).
Show all 11Show fewer
- 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.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48106
Northwestern University
Chicago, Illinois, 60611
University of Iowa
Iowa City, Iowa, 52242
University of California Los Angeles/University of Southern California
Los Angeles, California, 90095
University of Washington, Seattle
Seattle, Washington, 98195
Washington University, St. Louis
St Louis, Missouri, 63119
About this study
Official title: MAPP Research Network: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
Read the detailed description
To better understand the etiology and treated natural history of UCPPS, and to identify clinical factors and research measurements to define clinically relevant sub-groups of these patients for future clinical trials, and to inform symptom management, the NIDDK established the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network in 20089 (http://www.mappnetwork.org/). The primary clinical research effort carried out by this network in Phase I was a prospective cohort study, the Trans-MAPP Epidemiology/Phenotyping (EP) Study.10 From 12/14/2009 through 12/14/2012 1,039 men and women were enrolled, including persons with UCPPS (n=424); persons with other co-morbid illnesses, including fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome (n=200 for all conditions); and healthy controls (n=415). Study participants were extensively characterized (i.e., phenotyped) at baseline, and UCPPS participants were followed for 12 months. During follow-up, using a web-based symptom data capture system, a small battery of self-report questionnaires were repeated on a bi-weekly schedule for 48 weeks. In addition, neuroimaging was performed in a subset of participants (n=279) at baseline, and biological samples were collected on all participants at baseline and follow-up for studies to identify plasma and urine biomarkers and potential infectious agents. This study was complemented by a number of Discovery Site-Specific clinical research studies (i.e., studies generally conducted at a single site) and investigations of animal models developed by multiple sites to mimic symptoms of human UCPPS.
Initial analyses of these data have identified a number of provocative findings. There are strong indications those certain subgroups of participants (albeit with small sample sizes) with urinary and non-urinary symptoms tend to improve over time; whereas other subgroups tend to worsen over time. These patterns of improving or worsening are differentially expressed according to sex, subtype of bladder pain syndrome (BPS), and pain location (localized to the pelvic region vs pain reported in the pelvic region and beyond).
The second phase of the MAPP Network is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS). This follow-up study will have pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
This proposed MAPP Phase II SPS also presents the opportunity to apply many of the most promising research methods in the pain field (e.g. functional, chemical and structural neuroimaging, quantitative sensory testing) during the course of the study (at baseline and then longitudinally) to better characterize men and women with UCPPS. Most of these measures were only collected at a single point in time in the Trans-MAPP Epidemiology/Phenotyping Study of Phase I, and within a sample of UCPPS patients not enriched with predefined subgroups. Further phenotyping in the second phase study will allow us to better determine which of these measures, or any other measures identified during Phase I (e.g., urinary or serum biomarkers), might identify individuals most likely to have spontaneous improvement of their symptoms, versus transition to a more "peripheral" (pelvic pain only) or "centralized" form (pelvic pain and beyond) of urinary and non-urinary pain.
Eligible participants will be asked to participate in the study for up to 36 months. During which they will be asked to complete a series of in-clinic study visits that will at various time points a neuroimaging scan and quantitative sensory tests, online internet-based questionnaires in clinic and off site/at home (assessing symptoms, health care utilization, flare status, and quality of life), a physical exam, a pelvic exam, and prostate massage (optional for males only).
- Conditions
- Interstitial Cystitis, Chronic Prostatitis
- Keywords
- pelvic pain, bladder pain
- Medical subject headings
- Cystitis, Interstitial, Pelvic Pain
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 |
|---|---|---|
| UCPPS patients | All participants in this study are men or women who have been diagnosed with Urologic Chronic Pelvic Pain Syndrome (UCPPS). Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of pelvic pain (PP) only. In addition, enrichment recruitment of 240 UCPPS patients (120 males; 120 females) will also be targeted for those who answer "no" to questionaire question about specific Bladder pain symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity Score
The Pain severity Score is constructed from the GUPI pain subscale score (0-23) and ICSI Q4: Bladder pain score (0-5), summed to create a primary outcome for UCPPS pain, ranging from 0 to 28.
Measured: 48 weeks
Urinary Severity Score
The Urinary Severity Score is constructed from the GUPI urinary subscale score (0-10) and sum of ICSI Q1: Strong need to urinate (0-5), ICSI Q2: Frequency (0-5), and ICSI Q3: Frequency at night (0-5), summed to create a primary outcome for urinary symptoms, ranging from 0 to 25.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start1 Jul 2015
- Primary completionMar 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- 640 participants (estimated)
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, MSCI, Study chair, University of MichiganChris Mullins, PhD, Study director, NIDDK, NIHJ. Richard Landis, PhD, Study director, University of Pennsylvania, DCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514265
- Sponsor's protocol ID
- 822352
- Other IDs
- 5U01DK082316-02
- Acronym
- MAPP II SPS
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2015
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Clemens JQ, Naliboff BD, Bradley CS, Yang CC, Clauw DJ, Williams D, Lai HH, Sutcliffe S, Harte SE, Spitznagle T, Landis JR. Transitions From Regional to Widespread Pain in Urologic Chronic Pelvic Pain Syndrome: A Multidisciplinary Approach to the Study of Chronic Pelvic Pain II Research Network Study. J Urol. 2026 Jun;215(6):746-755. doi: 10.1097/JU.0000000000004943. Epub 2026 Jan 21.
PubMed 41564284Schrepf A, Locke K, Moldwin R, Williams DA, Till S, Farrar J, Richard Landis J, Tu F, Rodriguez L, Lai H, Naliboff B, Kutch J, Harte SE, Harris RE, Kreder KJ, Spitznagle T, McKernan L, Yang C, Quentin Clemens J, Mullins C, Clauw DJ. Widespread Pain Moderates the Response to Centrally-Acting Therapies in an Observational Cohort of Patients With Urologic Chronic Pelvic Pain Syndrome: A MAPP Research Network Study. Neurourol Urodyn. 2025 Aug;44(6):1290-1295. doi: 10.1002/nau.70068. Epub 2025 May 25.
PubMed 40415481Naliboff BD, McWilliams T, Clemens JQ, Pontari MA, Stephens-Shields AJ, Moldwin R, Sutcliffe S, Mullins C, Landis JR. Relationship of Sex and Diagnosis With Symptoms and Illness Impact in Urologic Chronic Pelvic Pain; A Mapp Network Analysis. Neurourol Urodyn. 2025 Feb;44(2):400-408. doi: 10.1002/nau.25648. Epub 2024 Dec 20.
PubMed 39704257Leech KA, Kettlety SA, Mack WJ, Kreder KJ, Schrepf A, Kutch JJ. Brain predicted age in chronic pelvic pain: a study by the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network. Pain. 2025 May 1;166(5):1060-1069. doi: 10.1097/j.pain.0000000000003424. Epub 2024 Oct 16.
PubMed 39432808Schrepf AD, Mawla I, Naliboff BD, Gallop B, Moldwin RM, Tu F, Gupta P, Harte S, Krieger JN, Yang C, Bradley C, Rodriguez L, Williams D, Magnotta V, Ichesco E, Harris RE, Clemens Q, Mullins C, Kutch JJ. Neurobiology and long-term impact of bladder-filling pain in humans: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) research network study. Pain. 2023 Oct 1;164(10):2343-2351. doi: 10.1097/j.pain.0000000000002944. Epub 2023 Jun 6.
PubMed 37278657Schrepf A, Kaplan C, Harris RE, Williams DA, Clauw DJ, As-Sanie S, Till S, Clemens JQ, Rodriguez LV, Van Bokhoven A, Landis R, Gallop R, Bradley C, Naliboff B, Pontari M, O'Donnell M, Luo Y, Kreder K, Lutgendorf SK, Harte SE. Stimulated whole-blood cytokine/chemokine responses are associated with interstitial cystitis/bladder pain syndrome phenotypes and features of nociplastic pain: a multidisciplinary approach to the study of chronic pelvic pain research network study. Pain. 2023 May 1;164(5):1148-1157. doi: 10.1097/j.pain.0000000000002813.
PubMed 36279178Naliboff BD, Schrepf AD, Stephens-Shields AJ, Clemens JQ, Pontari MA, Labus J, Taple BJ, Rodriguez LV, Strachan E, Griffith JW. Temporal Relationships between Pain, Mood and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study. J Urol. 2021 Jun;205(6):1698-1703. doi: 10.1097/JU.0000000000001595. Epub 2021 Feb 4.
PubMed 33535797
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAPP Research Network: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
- ClinicalTrials.gov ID
- NCT02514265
- Acronym / sponsor ID
- MAPP II SPS / 822352
- Conditions
- Interstitial Cystitis, Chronic Prostatitis
- Keywords
- pelvic pain, bladder pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (estimated)
- 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
- 1 Jul 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 3 Aug 2015 (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.
This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
Detailed description
To better understand the etiology and treated natural history of UCPPS, and to identify clinical factors and research measurements to define clinically relevant sub-groups of these patients for future clinical trials, and to inform symptom management, the NIDDK established the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network in 20089 (http://www.mappnetwork.org/). The primary clinical research effort carried out by this network in Phase I was a prospective cohort study, the Trans-MAPP Epidemiology/Phenotyping (EP) Study.10 From 12/14/2009 through 12/14/2012 1,039 men and women were enrolled, including persons with UCPPS (n=424); persons with other co-morbid illnesses, including fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome (n=200 for all conditions); and healthy controls (n=415). Study participants were extensively characterized (i.e., phenotyped) at baseline, and UCPPS participants were followed for 12 months. During follow-up, using a web-based symptom data capture system, a small battery of self-report questionnaires were repeated on a bi-weekly schedule for 48 weeks. In addition, neuroimaging was performed in a subset of participants (n=279) at baseline, and biological samples were collected on all participants at baseline and follow-up for studies to identify plasma and urine biomarkers and potential infectious agents. This study was complemented by a number of Discovery Site-Specific clinical research studies (i.e., studies generally conducted at a single site) and investigations of animal models developed by multiple sites to mimic symptoms of human UCPPS.
Initial analyses of these data have identified a number of provocative findings. There are strong indications those certain subgroups of participants (albeit with small sample sizes) with urinary and non-urinary symptoms tend to improve over time; whereas other subgroups tend to worsen over time. These patterns of improving or worsening are differentially expressed according to sex, subtype of bladder pain syndrome (BPS), and pain location (localized to the pelvic region vs pain reported in the pelvic region and beyond).
The second phase of the MAPP Network is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS). This follow-up study will have pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
This proposed MAPP Phase II SPS also presents the opportunity to apply many of the most promising research methods in the pain field (e.g. functional, chemical and structural neuroimaging, quantitative sensory testing) during the course of the study (at baseline and then longitudinally) to better characterize men and women with UCPPS. Most of these measures were only collected at a single point in time in the Trans-MAPP Epidemiology/Phenotyping Study of Phase I, and within a sample of UCPPS patients not enriched with predefined subgroups. Further phenotyping in the second phase study will allow us to better determine which of these measures, or any other measures identified during Phase I (e.g., urinary or serum biomarkers), might identify individuals most likely to have spontaneous improvement of their symptoms, versus transition to a more "peripheral" (pelvic pain only) or "centralized" form (pelvic pain and beyond) of urinary and non-urinary pain.
Eligible participants will be asked to participate in the study for up to 36 months. During which they will be asked to complete a series of in-clinic study visits that will at various time points a neuroimaging scan and quantitative sensory tests, online internet-based questionnaires in clinic and off site/at home (assessing symptoms, health care utilization, flare status, and quality of life), a physical exam, a pelvic exam, and prostate massage (optional for males only).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCPPS patients | – | –All participants in this study are men or women who have been diagnosed with Urologic Chronic Pelvic Pain Syndrome (UCPPS). Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of pelvic pain (PP) only. In addition, enrichment recruitment of 240 UCPPS patients (120 males; 120 females) will also be targeted for those who answer "no" to questionaire question about specific Bladder pain symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Trans-MAPP SPS study will include adults 18 years and older with urological pelvic pain syndromes. Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of Pelvis pain only.
Key inclusion criteria (10 listed)
- Participant has signed and dated the appropriate Informed Consent document.
- Participant is at least 18 years of age.
- Participant is able to speak, read, and understand English.
- In the past 3 months participant has had a feeling of pain, pressure, or discomfort in the lower abdomen or pelvic area -- that is, the part of the body that is above the participant's legs and below the belly button.
- These symptoms have been present for the majority of the time during the most recent 3 months.
Key exclusion criteria (11 listed)
- Any patient meeting any one of the following criteria will not be eligible for enrollment in the Symptom Patterns Study. However, participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed. It will be recorded in the follow-up data if a patient has developed any of the exclusion 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, 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
Pain Severity Score
Time frame: 48 weeks
The Pain severity Score is constructed from the GUPI pain subscale score (0-23) and ICSI Q4: Bladder pain score (0-5), summed to create a primary outcome for UCPPS pain, ranging from 0 to 28.
Urinary Severity Score
Time frame: 48 weeks
The Urinary Severity Score is constructed from the GUPI urinary subscale score (0-10) and sum of ICSI Q1: Strong need to urinate (0-5), ICSI Q2: Frequency (0-5), and ICSI Q3: Frequency at night (0-5), summed to create a primary outcome for urinary symptoms, ranging from 0 to 25.
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 9 Jul 2020.
- Derived from this study: PubMed 41564284Clemens JQ, Naliboff BD, Bradley CS, Yang CC, Clauw DJ, Williams D, Lai HH, Sutcliffe S, Harte SE, Spitznagle T, Landis JR. Transitions From Regional to Widespread Pain in Urologic Chronic Pelvic Pain Syndrome: A Multidisciplinary Approach to the Study of Chronic Pelvic Pain II Research Network Study. J Urol. 2026 Jun;215(6):746-755. doi: 10.1097/JU.0000000000004943. Epub 2026 Jan 21.
- Derived from this study: PubMed 40415481Schrepf A, Locke K, Moldwin R, Williams DA, Till S, Farrar J, Richard Landis J, Tu F, Rodriguez L, Lai H, Naliboff B, Kutch J, Harte SE, Harris RE, Kreder KJ, Spitznagle T, McKernan L, Yang C, Quentin Clemens J, Mullins C, Clauw DJ. Widespread Pain Moderates the Response to Centrally-Acting Therapies in an Observational Cohort of Patients With Urologic Chronic Pelvic Pain Syndrome: A MAPP Research Network Study. Neurourol Urodyn. 2025 Aug;44(6):1290-1295. doi: 10.1002/nau.70068. Epub 2025 May 25.
- Derived from this study: PubMed 39704257Naliboff BD, McWilliams T, Clemens JQ, Pontari MA, Stephens-Shields AJ, Moldwin R, Sutcliffe S, Mullins C, Landis JR. Relationship of Sex and Diagnosis With Symptoms and Illness Impact in Urologic Chronic Pelvic Pain; A Mapp Network Analysis. Neurourol Urodyn. 2025 Feb;44(2):400-408. doi: 10.1002/nau.25648. Epub 2024 Dec 20.
- Derived from this study: PubMed 39432808Leech KA, Kettlety SA, Mack WJ, Kreder KJ, Schrepf A, Kutch JJ. Brain predicted age in chronic pelvic pain: a study by the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network. Pain. 2025 May 1;166(5):1060-1069. doi: 10.1097/j.pain.0000000000003424. Epub 2024 Oct 16.
- Derived from this study: PubMed 37278657Schrepf AD, Mawla I, Naliboff BD, Gallop B, Moldwin RM, Tu F, Gupta P, Harte S, Krieger JN, Yang C, Bradley C, Rodriguez L, Williams D, Magnotta V, Ichesco E, Harris RE, Clemens Q, Mullins C, Kutch JJ. Neurobiology and long-term impact of bladder-filling pain in humans: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) research network study. Pain. 2023 Oct 1;164(10):2343-2351. doi: 10.1097/j.pain.0000000000002944. Epub 2023 Jun 6.
- Derived from this study: PubMed 36279178Schrepf A, Kaplan C, Harris RE, Williams DA, Clauw DJ, As-Sanie S, Till S, Clemens JQ, Rodriguez LV, Van Bokhoven A, Landis R, Gallop R, Bradley C, Naliboff B, Pontari M, O'Donnell M, Luo Y, Kreder K, Lutgendorf SK, Harte SE. Stimulated whole-blood cytokine/chemokine responses are associated with interstitial cystitis/bladder pain syndrome phenotypes and features of nociplastic pain: a multidisciplinary approach to the study of chronic pelvic pain research network study. Pain. 2023 May 1;164(5):1148-1157. doi: 10.1097/j.pain.0000000000002813.
- Derived from this study: PubMed 33535797Naliboff BD, Schrepf AD, Stephens-Shields AJ, Clemens JQ, Pontari MA, Labus J, Taple BJ, Rodriguez LV, Strachan E, Griffith JW. Temporal Relationships between Pain, Mood and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study. J Urol. 2021 Jun;205(6):1698-1703. doi: 10.1097/JU.0000000000001595. Epub 2021 Feb 4.
- 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, MSCI study chair
University of Michigan
Chris Mullins, PhD study director
NIDDK, NIH
J. Richard Landis, PhD study director
University of Pennsylvania, DCC
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 10 inclusion and 11 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 9 Jul 2020. 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: 48 weeks). 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?
On the ClinicalTrials.gov record for NCT02514265, which also lists 7 linked publications.
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 9 Jul 2020.