Clinical trial NCT02514265: Trans-MAPP Symptom Patterns Study (SPS)
Official title: MAPP Research Network: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Chronic Prostatitis
Keywords: pelvic pain, bladder pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Colorado, Denver
First posted: 2015-08-03
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Trans-MAPP SPS study will include adults 18 years and older with urological pelvic pain syndromes. Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of Pelvis pain only.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Severity Score
timeFrame: 48 weeks
measure: Urinary Severity Score
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles/University of Southern California
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University, St. Louis
state: Missouri
city: Seattle
country: United States
facility: University of Washington, Seattle
state: Washington
Study officials:
affiliation: University of Michigan
name: J.Quentin Clemens, MD, MSCI
role: STUDY_CHAIR
affiliation: NIDDK, NIH
name: Chris Mullins, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania, DCC
name: J. Richard Landis, PhD
role: STUDY_DIRECTOR
References:
citation: Naliboff BD, Schrepf AD, Stephens-Shields AJ, Clemens JQ, Pontari MA, Labus J, Taple BJ, Rodriguez LV, Strachan E, Griffith JW. Temporal Relationships between Pain, Mood and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study. J Urol. 2021 Jun;205(6):1698-1703. doi: 10.1097/JU.0000000000001595. Epub 2021 Feb 4.