protocolSection identificationModule nctId: NCT06299683, orgStudyIdInfo id: 230487, secondaryIdInfos id: 1R01DK133415-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DK133415-01A1, briefTitle: Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-05, completionDateStruct date: 2028-08-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS., conditionsModule conditions: Chronic Interstitial Cystitis, conditions: Bladder Pain Syndrome, conditions: Painful Bladder Syndrome, conditions: Cystitis, Interstitial, conditions: Cystitis, Chronic Interstitial, conditions: Interstitial Cystitis, conditions: Interstitial Cystitis, Chronic, conditions: Interstitial Cystitis (Chronic) With Hematuria, conditions: Interstitial Cystitis (Chronic) Without Hematuria, conditions: Chronic Prostatitis, conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Study assessors will be blinded to the study primary outcome but will be aware of study treatment conditions., enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Psychosocial Treatment, interventions name: Pelvic Floor Physical Therapy, outcomesModule primaryOutcomes measure: Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale., secondaryOutcomes measure: Chronic Overlapping Pain Condition-Screener (COPCS), secondaryOutcomes measure: Quantitative Sensory Testing - Tolerance Average (QST-TOL), secondaryOutcomes measure: Quantitative Sensory Testing - Threshold Average (QST-THR), secondaryOutcomes measure: Quantitative Sensory Testing - Temporal Summation (QST-TS), secondaryOutcomes measure: Urinary Nerve Growth Factor (NGF), secondaryOutcomes measure: Urinary Interleukin-6 (IL6), secondaryOutcomes measure: Interleukin-6, whole blood stimulated (IL6-LPS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False