Trans-MAPP Symptom Patterns Study (SPS)

Interstitial Cystitis Clinical Trial

— MAPP II SPS  

Official title:

MAPP Research Network: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514265
• Other study ID #: 822352
• Secondary ID: 5U01DK082316-02
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: June 2020

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

To better understand the etiology and treated natural history of UCPPS, and to identify clinical factors and research measurements to define clinically relevant sub-groups of these patients for future clinical trials, and to inform symptom management, the NIDDK established the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network in 20089 (http://www.mappnetwork.org/). The primary clinical research effort carried out by this network in Phase I was a prospective cohort study, the Trans-MAPP Epidemiology/Phenotyping (EP) Study.10 From 12/14/2009 through 12/14/2012 1,039 men and women were enrolled, including persons with UCPPS (n=424); persons with other co-morbid illnesses, including fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome (n=200 for all conditions); and healthy controls (n=415). Study participants were extensively characterized (i.e., phenotyped) at baseline, and UCPPS participants were followed for 12 months. During follow-up, using a web-based symptom data capture system, a small battery of self-report questionnaires were repeated on a bi-weekly schedule for 48 weeks. In addition, neuroimaging was performed in a subset of participants (n=279) at baseline, and biological samples were collected on all participants at baseline and follow-up for studies to identify plasma and urine biomarkers and potential infectious agents. This study was complemented by a number of Discovery Site-Specific clinical research studies (i.e., studies generally conducted at a single site) and investigations of animal models developed by multiple sites to mimic symptoms of human UCPPS.

Initial analyses of these data have identified a number of provocative findings. There are strong indications those certain subgroups of participants (albeit with small sample sizes) with urinary and non-urinary symptoms tend to improve over time; whereas other subgroups tend to worsen over time. These patterns of improving or worsening are differentially expressed according to sex, subtype of bladder pain syndrome (BPS), and pain location (localized to the pelvic region vs pain reported in the pelvic region and beyond).

The second phase of the MAPP Network is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS). This follow-up study will have 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.

This proposed MAPP Phase II SPS also presents the opportunity to apply many of the most promising research methods in the pain field (e.g. functional, chemical and structural neuroimaging, quantitative sensory testing) during the course of the study (at baseline and then longitudinally) to better characterize men and women with UCPPS. Most of these measures were only collected at a single point in time in the Trans-MAPP Epidemiology/Phenotyping Study of Phase I, and within a sample of UCPPS patients not enriched with predefined subgroups. Further phenotyping in the second phase study will allow us to better determine which of these measures, or any other measures identified during Phase I (e.g., urinary or serum biomarkers), might identify individuals most likely to have spontaneous improvement of their symptoms, versus transition to a more "peripheral" (pelvic pain only) or "centralized" form (pelvic pain and beyond) of urinary and non-urinary pain.

Eligible participants will be asked to participate in the study for up to 36 months. During which they will be asked to complete a series of in-clinic study visits that will at various time points a neuroimaging scan and quantitative sensory tests, online internet-based questionnaires in clinic and off site/at home (assessing symptoms, health care utilization, flare status, and quality of life), a physical exam, a pelvic exam, and prostate massage (optional for males only).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: June 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients are eligible for the SPS if they meet the following criteria:

1. 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.

2. Participant is at least 18 years of age.

3. Participant is able to speak, read, and understand English.

4. 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.

5. These symptoms have been present for the majority of the time during the most recent 3 months.

6. Participant reports a response of at least 1 on the pain, pressure or discomfort scale for UCPPS symptoms during the past 2 weeks.

7. 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.

Exclusion Criteria:

Any patient meeting any one of the following criteria will not be eligible for enrollment in the Symptom Patterns Study. However, participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed. It will be recorded in the follow-up data if a patient has developed any of the exclusion criteria.

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 an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).

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. Diagnosis of unilateral orchalgia, without pelvic symptoms.

2. History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.

Related Conditions & MeSH terms

• Chronic Prostatitis
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Prostatitis

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Northwestern University	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa
United States	University of California Los Angeles/University of Southern California	Los Angeles	California
United States	Washington University, St. Louis	Saint Louis	Missouri
United States	University of Washington, Seattle	Seattle	Washington

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	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
Primary	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

External Links

•   MAPP Research Network Website