NCT02514265

Brief 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 associated with worsening and/or improvement of reported urinary and non-urinary symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3.7 years

First QC Date

July 30, 2015

Last Update Submit

July 8, 2020

Conditions

Interstitial CystitisChronic Prostatitis

Keywords

pelvic pain, bladder pain

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    48 weeks

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California Los Angeles/University of Southern California

Los Angeles, California, 90095, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63119, United States

Location

University of Washington, Seattle

Seattle, Washington, 98195, United States

Location

Related Publications (6)

  • Schrepf 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.

    PMID: 40415481DERIVED

  • Naliboff 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.

    PMID: 39704257DERIVED

  • Leech 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.

    PMID: 39432808DERIVED

  • Schrepf 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.

    PMID: 37278657DERIVED

  • Schrepf 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.

    PMID: 36279178DERIVED

  • Naliboff 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.

    PMID: 33535797DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

DNA Blood Urine Vaginal Swabs Rectal Swab

MeSH Terms

Conditions

Cystitis, InterstitialPelvic Pain

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • J.Quentin Clemens, MD, MSCI

    University of Michigan

    STUDY CHAIR

  • Chris Mullins, PhD

    NIDDK, NIH

    STUDY DIRECTOR

  • J. Richard Landis, PhD

    University of Pennsylvania, DCC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2019

Study Completion

June 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

US(6)