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Trans-MAPP II Study of Urologic Chronic Pelvin Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898220
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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 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.

Condition or disease
Interstitial Cystitis Chronic Prostatitis

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.

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Control Study Protocol
Study Start Date : September 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain




Primary Outcome Measures :
  1. 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)

  2. 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


Biospecimen Retention:   Samples With DNA
Biologic specimens collected during the course of the study include urine, blood, saliva, and rectal and vaginal swabs.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The Trans-MAPP II control study will recruit healthy controls (male and female) over a two year period.
Criteria

Inclusion Criteria:

  • 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.
  • 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.

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).
  • 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.
  • 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.

Exclusion Criteria for Males Only:

  • 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.

Exclusion Criteria for Females Only:

• 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.

Exclusion Criteria - Urine test results:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898220


Contacts
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Contact: Nancy Robinson, Ph.D. 215-573-4421 narobins@upenn.edu
Contact: Sally Thompson, M.B.E 215-573-8926 sallyj@mail.med.upenn.edu

Locations
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United States, California
University of California, Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Suzanne R Smith, RN, NP    310-206-0310    srsmith@mednet.ucla.edu   
Principal Investigator: Emeran A Mayer, MD         
Principal Investigator: Larissa V Rodriguez, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Darlene Marko, RN,BSN,CCRC    312-695-3898    d-marko@northwestern.edu   
Principal Investigator: David J Klumpp, PhD         
Principal Investigator: Anthony J Schaeffer, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Eno, RN, RA II    319-384-9265    mary-eno@uiowa.edu   
Principal Investigator: Karl J Kreder, MD, MBA         
United States, Michigan
University of Michigan, Ann Arbor Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Megan E Halvorson, BS, CCRP    734-998-6839    meganeb@med.umich.edu   
Contact: Clara Grayhack, BS       cgrayhac@med.umich.edu   
Principal Investigator: Daniel J Clauw, MD         
Principal Investigator: J. Quentin Clemens, MD, MSCI         
United States, Missouri
Washington University, St. Louis Recruiting
Saint Louis, Missouri, United States, 63119
Contact: Vivien C Gardner, RN, BSN    314-747-6192    gardnerv@wudosis.wustl.edu   
Principal Investigator: Gerald L Andriole, MD         
Principal Investigator: H. Henry Lai, MD         
United States, Washington
University of Washington, Seattle Recruiting
Seattle, Washington, United States, 98195
Contact: Stephanie Richey, Bs    206-708-8672    mappuw@uw.edu   
Contact: Kelly Robertson    206-708-8678    mappuw@uw.edu   
Principal Investigator: Dedra Buchwald, MD         
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Investigators
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Study Director: Richard Landis, Ph.D. University of Pennsylvania
Study Director: Christopher Mullins, Ph.D NIDDK, NIH
Study Director: J. Quentin Clemens, MD, MSCI University of Michigan

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02898220    
Other Study ID Numbers: 825428
U01DK082316 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plans are still to be finalized
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Prostatitis
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases
Genital Diseases, Male