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

Interstitial Cystitis Clinical Trial

— MAPP-EP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098279
• Other study ID #: 810643
• Secondary ID: U01DK082316
• Status: Completed
• Start date: December 2009
• Est. completion date: June 2014

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Prostatitis
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Pelvic Pain
• Prostatitis

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa
United States	University of California, Los Angeles	Los Angeles	California
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal outcomes for MAPP Participants	Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP EP Study. These measures can be classified into a number of primary domains as described below.; Single point in time: this includes measures that do not change over time, such as demographic information, "trait measures" (e.g., personality), and early life history measures. In general, these measures are collected at the initial in-person clinic visit, although some are collected in the second (6-month) in-person visit to reduce participant burden at baseline; Baseline, 6-month and 12-month phenotyping in-clinic visits; Bi-monthly personal internet-based assessment; Bi-weekly personal internet-based assessment.	Baseline/6 month/12 month/ bi-weekly/bi-monthly

External Links

•   MAPP Research Network Website