BackgroundThe “Multidisciplinary Approach to the Study of Chronic Pelvic Pain” (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network’s central study and common data elements are described.MethodsThe primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as “positive” controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing.DiscussionThe MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based.Trial registrationClinicalTrials.gov identifier: NCT01098279 “Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)”. http://clinicaltrials.gov/show/NCT01098279

Irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome are more prevalent in patients with interstitial cystitis/painful bladder syndrome than in asymptomatic control subjects, and result in significant impact. There are at least 3 distinct clinical phenotypes based on identification of overlapping syndrome patterns. A suggestion that remains to be proven with longitudinal studies is that there may be progression over time from an organ centric to a regional and finally to a systemic pain syndrome with progression of symptom severity, and deterioration of cognitive and psychosocial parameters.

OBJECTIVE The purpose of this trial was to compare usual patient education plus the Internet-based, Personal Patient Profile-Prostate, versus usual education alone, on conflict associated with decision making, plus explore time-to-treatment and treatment choice. METHODS A randomized, multi-center clinical trial was conducted with measures at baseline, one and six months. Men with newly diagnosed localized prostate cancer who sought consultation at urology, radiation oncology or multi-disciplinary clinics in four geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using Generalized Estimating Equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice and program acceptability/usefulness, were explored. RESULTS A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time as compared with the control group, for the uncertainty score (estimate −3.61; (confidence interval, −7.01,−0.22) and values clarity (estimate −3.57; confidence interval (−5.85,−1.30) Borderline effect was seen for the total decisional conflict score (estimate −1.75; confidence interval (−3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized prostate cancer. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a prostate cancer treatment that is consistent with the patient values and preferences.

Patients with interstitial cystitis/painful bladder syndrome have significant cognitive and psychosocial alterations compared to controls.

Purpose The pathophysiology of interstitial cystitis/painful bladder syndrome (IC/PBS) remains incompletely understood, but is thought to involve a central disturbance in the processing of pain and viscerosensory signals. We aimed to identify differences in brain activity and connectivity between female IC/PBS patients and healthy controls in order to advance clinical phenotyping and treatment efforts for IC/PBS. Materials and Methods We examined oscillation dynamics of intrinsic brain activity in a large sample of well-phenotyped female IC/PBS patients and female healthy controls collected during a 10-minute resting fMRI scan as part of the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network* project. The BOLD signal was transformed to the frequency domain and relative power was computed for multiple frequency bands. Results The results demonstrated altered frequency distributions in a viscerosensory region (post Insula) and sensorimotor cortices (postcentral gyrus, paracentral lobule, supplementary motor area (SMA), including a region likely involved in control of pelvic floor muscles (PelMotor). Additionally, the SMA, paracentral lobule and PelMotor all demonstrated increased functional connectivity to the midbrain (red nucleus) and cerebellum. This increased functional connectivity was greatest in patients reporting pain during bladder filling. Conclusions These findings suggest that women with IC/PBS have a neuromotor component to their pathology involving an alteration in the intrinsic oscillations and connectivity within a cortico-cerebellar network previously associated with urinary bladder function.

Background-Amitriptyline is frequently used to treat patients with IC/PBS. The evidence to support this practice is derived mainly from a small single site clinical trial and case reports.

Objectives To determine the efficacy and safety of pelvic floor Myofascial Physical Therapy (MPT) in women with newly-symptomatic IC/PBS, as compared to Global Therapeutic Massage (GTM). Materials and Methods A randomized controlled trial of 10 scheduled treatments of MPT vs. GTM was performed at 11 clinical centers located in North America. We recruited women with IC/PBS with demonstrable pelvic floor tenderness on physical examination and a limitation of no more than 3 years symptom duration. The primary outcome was the proportion of responders defined as ‘moderately improved’ or ‘markedly improved’ in overall symptoms compared to baseline on a 7-point scale Global Response Assessment (GRA). Secondary outcomes included ratings for pain, urgency, frequency; the O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) and reports of adverse events. We compared response rates between treatment arms using the exact conditional version of the Mantel-Haenszel test to control for clustering by clinical center. For secondary efficacy outcomes, cross-sectional descriptive statistics and changes from baseline were calculated. Results Eighty-one women randomized to the two treatment groups had similar symptoms at baseline. The GRA response rate was 26% in the GTM group and 59% in the MPT group (p=0.0012). Pain, urgency, and frequency ratings and in ICSI/ICPI decreased in both groups during follow-up and were not significantly different between the groups. Pain was the most common adverse event, occurring at similar rates in both groups. There were no serious adverse events reported. Conclusions A significantly higher proportion of women with IC/PBS reponded to treatment with MPT than with GTM. MPT may be a beneficial therapy in women with this syndrome.

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