SPS Design and Data/Biosample Domains

The MAPP Network’s MAPP II Symptoms Patterns Study (SPS) was a multi-site cohort study of males and females with UCPPS. It featured a novel run-in period prior to a baseline in-clinic visit, followed by quarterly assessments for up to 36-months. “Healthy” controls participants were also recruited and assessed at baseline and at 6-months.

Eligibility (inclusion and exclusion) criteria for the SPS were intentionally similar to the original EPS criteria. One exception was that former EPS participants could re-enroll in SPS with a current pain/pressure/discomfort score of 0, to provide insight into factors associated with symptom resolution (i.e., since their participation in the EPS). Modified recruitment goals for SPS included 620 UCPPS participants, divided equally among men and women, and 72 healthy controls.

The SPS was designed to provide more comprehensive, integrated cross-modality assessment of clinical, biological and pain sensitivity measures, as well as longer follow-up (144 weeks), compared to the MAPP I EPS (48 weeks). Based on findings from the EPS, additional study features were included in SPS, such as the novel 4-week run-in period with weekly assessments prior to planned “baseline” in-clinic data and biosample/measures collection, performed at the 4-week (fifth) visit. This run-in period allowed an assessment of outcome variability and propensity to adjust for potential “regression-to-the-mean” phenomena. Detailed information about targeted usual‐care therapy and treatment response was also collected to identify UCPPS participants with the potential to preferentially respond to different therapies. Data for the UCPPS participants were obtained at 3-monthly interval contacts over the course of 36 months, with in-clinic deep phenotyping visits conducted at baseline, 6 months, 18 months and 36 months. See Figure 8 for the EPS study design and visit schedule.

During the SPS extensive clinical data assessing urological symptoms, non-urological pain, chronic overlapping pain syndromes, and psychosocial factors were collected. In addition, diverse biospecimens for biomarker and microbiome studies; quantitative sensory testing (QST) data from multiple stimuli; and structural and functional neuroimaging scans, including for a novel natural bladder filling study (“Water Ingestion Protocol”), were obtained during in-clinic visits under the standardized SPS protocol.