Trans-MAPP II Study of Urologic Chronic Pelvin Pain



Status:Recruiting
Conditions:Other Indications, Urology, Urology
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:September 2016
End Date:December 2019
Contact:Nancy Robinson, Ph.D.
Email:narobins@upenn.edu
Phone:215-573-4421

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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.

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.

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.
We found this trial at
6
sites
Seattle, Washington 98195
Principal Investigator: Dedra Buchwald, MD
Phone: 206-708-8672
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Karl J Kreder, MD, MBA
Phone: 319-384-9265
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Ann Arbor, Michigan 48105
Principal Investigator: Daniel J Clauw, MD
Phone: 734-998-6839
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Ann Arbor, MI
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: David J Klumpp, PhD
Phone: 312-695-3898
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Chicago, IL
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Los Angeles, California 90095
Principal Investigator: Emeran A Mayer, MD
Phone: 310-206-0310
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Los Angeles, CA
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Saint Louis, Missouri 63110
Principal Investigator: Gerald L Andriole, MD
Phone: 314-747-6192
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Saint Louis, MO
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