Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/ or Chronic Prostatitis



Status:Completed
Conditions:Other Indications, Women's Studies, Urology
Therapuetic Areas:Nephrology / Urology, Other, Reproductive
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:December 2009
End Date:June 2013
Contact:Nancy Robinson, PhD
Email:narobins@mail.med.upenn.edu

Use our guide to learn which trials are right for you!

Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Epidemiology and Phenotyping (EP) Study

The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network
has been established to focus on a broader approach to the study of Interstitial Cystitis
(IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic
Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Participants with some form
or symptoms of IC or CP are being asked to join the Trans-MAPP Epidemiology and Phenotyping
(EP) Study.

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. The MAPP EP Study is an observational study that will enroll approximately 360
participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. We will ask
questions and gather information about the health and life of the participants for research
purposes. No study treatment or interventions will be given to participants in MAPP. We hope
that this study will lead to improvement in the treatment of IC and CP.

Potentially eligible participants will be scheduled for an eligibility screening session,
followed by an extensive baseline phenotyping session, which together are expected to take
approximately 2.5 hours to complete. Participants will be provided with breaks as needed
during the clinic visit. The eligibility screening session is intended to collect the
minimally sufficient data to confirm eligibility, so that the extensive baseline phenotyping
session is initiated only for participants highly likely to be confirmed after the 48 hour
urine culture results are known.

Participants who enroll in the study and complete a baseline clinic visit will be followed
up with bi-weekly and bi-monthly internet-based questionnaires, as well as in-clinic visits
at 6 and 12 months.

Participants will provide self-reported symptom data using web based internet tools on a
bi-weekly basis. These questions are expected to be completed within 5-7 minutes.

A more extensive set of questionnaires will be administered to each participant every two
months during the 12-month study period. The bi-monthly assessment will also be administered
via the internet, and the questions are expected to be completed within 10-15 minutes.

Inclusion Criteria:

Participants are eligible for the Trans-MAPP EP if they meet the following:

1. Participant has signed and dated the appropriate Informed Consent document.

2. Agreed to participate in Trans-MAPP EP Study procedures.

3. Participant reports a response of at least 1 on the pain, pressure or discomfort
scale.

For males or females (IC/PBS criteria)

1. Participant reports an unpleasant sensation of pain, pressure or discomfort, perceived
to be related to the bladder and/or pelvic region, associated with lower urinary tract
symptoms for the majority of the time during any 3 months in the previous 6 months or for
the majority of the time during the most recent 3 months.

For males only (CP/CPPS criteria)

1. Male participant reports pain or discomfort in any of the 8 domains of the Male
Genitourinary Pain Index for the majority of the time during any 3 months in the previous
6 months

Exclusion Criteria:

Individuals will not be eligible for enrollment in the Trans-MAPP EP Study if they meet
any of the criteria listed below. Participants who develop any of these exclusion criteria
during the follow-up phase of the study will continue to be followed, and included in the
cohort study.

1. Participant has an on-going symptomatic urethral stricture.

2. Participant has an on-going neurological disease or disorder affecting the bladder or
bowel fistula.

3. Participant has a history of cystitis caused by tuberculosis, radiation therapy or
Cytoxan/cyclophosphamide therapy.

4. Participant has augmentation cystoplasty or cystectomy.

5. Participant has a systemic autoimmune disorder (such as Crohn's Disease or Ulcerative
Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).

6. Participant has a history of cancer (with the exception of skin cancer).

7. 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).

8. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the
judgment of the study physician would preclude participation in this study.

Exclusion Criteria for Males Only

1. Male Participant diagnosed with unilateral orchalgia, without pelvic symptoms.

2. Male Participant has a history of transurethral microwave thermotherapy (TUMT),
transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or
laser procedure.

Exclusion Criteria for Females Only

1. Female Participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL)
/ high-grade cervical dysplasia.
We found this trial at
8
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
St Louis, Missouri 63110
?
mi
from
St Louis, MO
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials