Deep phenotyping of women with endometriosis-associated pain and bladder pain syndrome: the TRiPP (Translational Research in Pelvic Pain) study protocol

Objectives Chronic pelvic pain is common, poorly understood, and many women suffer for years without proper diagnosis and effective treatment. The Translational Research in Pelvic Pain (TRiPP) project takes a phenotyping approach, with a particular focus on endometriosis-associated pain (EAP) and bladder pain syndrome (IC/BPS), to improve our fundamental understanding of chronic pelvic pain. We believe that reconceptualising these conditions in the context of the multisystem dysfunction known for other chronic pain conditions rather than as end-organ pathologies has the potential to improve our understanding of the conditions. Our approach combines clinical, biological, physiological and psychological data to establish perturbations in the functions of pain-relevant systems that are specific to EAP and IC/BPS, and those that overlap both conditions and chronic pelvic pain more generally and associated quantitative biomarker profiles. Discussion We believe that TRiPP’s novel methodological approach will produce clinical data to aid our understanding of pelvic pain and identify underlying pathways for the development of refined animal models and targeted therapeutic treatments. ### Competing Interest Statement LD, L, MK, Nr, LAN, QA, JB, LH, JM and CS declare no competing interests. CMB: Research Grants from Bayer Healthcare, MDNA Life Sciences, Roche Diagnostics, European Commission, NIH. His employer has received consulancy fees from Myovant and ObsEva for work outside of this project. FC: Consultant and/or investigator for Allergan (Abbvie), Astellas, Bayer, Ipsen and Recordati AH: Employee of Bayer AG, Germany. AWH: reports grant funding from the MRC, NIHR, CSO, Wellbeing of Women, Roche Diagnostics, Astra Zeneca, Ferring, Charles Wolfson Charitable Trust and Standard Life. His employer has received consultancy fees from Roche Diagnostics, AbbVie, Nordic Pharma and Ferring, outside the submitted work. In addition, AWH has a patent for a serum biomarker for endometriosis pending. EMP-Z: received financial support from Grunenthal and Mundipharma for research activities and advisory and lecture fees from Grunenthal, Novartis and Mundipharma. In addition, she receives scientific support from the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), the German Federal Joint Committee (G-BA) and the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 777500. This Joint Undertaking receives support from the European Unions Horizon 2020 research and innovation programme and EFPIA. All money went to the institution E.M.P.-Z. is working for. IT: On the scientific advisory board for Amgen (2017 to 2019); has received honoraria for providing various educational talks and workshops; is a council member of the Medical Research Council of the United Kingdom; is a trustee of MQ, a mental health charity; is President-elect of FENS; and is involved with Innovative Medicines Initiative PainCare (Biopain), a pan pharma-academia consortium. RDT: Ad board for BAYER, IASP task force on chronic pain classification SAM: has been an advisory board member for AbbVie and Roche and receives research funding from the National Institutes of Health, the US Department of Defense, the J. Willard and Alice S. Marriott Foundation, and AbbVie; none are related to the presented work. KTZ: reports grant funding from EU Horizon 2020, NIH US, Wellbeing of Women, Bayer AG, Roche Diagnostics, Evotec-Lab282, MDNA Life Sciences, outside the submitted work. JN: Employee and shareholder of Bayer AG, Germany KV: declares research funding from Bayer Healthcare and honoraria for consultancy and talks and associated travel expenses from Bayer Healthcare, Grunenthal GmBH, AbbVie and Eli Lilly. ### Funding Statement This study was funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No [777500]. This Joint Undertaking receives support from the European Unions Horizon 2020 research and innovation programme and EFPIA. Further information is found under [www.imi-paincare.eu][1] and [www.imi.europa.eu][2]. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Yorkshire & The Humber, South Yorkshire Research Ethics Committee (19/YH/0030) gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: http://www.imi-paincare.eu [2]: http://www.imi.europa.eu