This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $6,154,752 to fund a 3-year clinical study on how menstrual pain (dysmenorrhea) and bladder hypersensitivity influence the development of chronic pelvic pain (CPP) conditions. The research, conducted by Northshore University Healthsystem Research Institute, aims to identify sensory mechanisms and biomarkers that predict...
The National Institute of Neurological Disorders and Stroke (NINDS) awarded a $6,522,833 Project Grant to The Leland Stanford Junior University to conduct a mechanistic randomized clinical trial investigating the central and peripheral nervous system mechanisms of pain relief induced by peripheral nerve stimulation (PNS) for the treatment of refractory chronic neuropathic pain. The 3-year study, funded under the NIH HEAL Initiative's CFDA 93.279 Drug Abuse and Addiction Research Programs, aims...
The National Institute of Neurological Disorders and Stroke (NINDS) awarded a $299,518 Project Grant under the Drug Abuse and Addiction Research Programs (CFDA 93.279) to V-Flow Medical Inc. to develop a novel diagnostic catheter and modular stent system to treat pelvic venous insufficiency (PVI), a primary cause of chronic pelvic pain (CPP) in women. The project will utilize an ovine model to evaluate the safety and efficacy of V-Flow's catheter and stent system in improving clinical outcomes...
This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Drug Use and Addiction Research Programs (CFDA 93.279), will validate a novel near-infrared spectroscopy (NIRS) optical imaging technology to quantify pelvic floor muscle fitness in patients with myofascial pelvic pain (MPP). The $1,516,765 award to the University of California, Los Angeles (UCLA) aims to establish NIRS as an effective, non-invasive method to assess pelvic floor muscle...
This Project Grant award from the National Institutes of Health (NIH) Trans-NIH Research Support program (CFDA 93.310) provides $250,000 to The Regents of the University of California, San Francisco (UCSF) to conduct a randomized trial evaluating the feasibility and efficacy of a remotely delivered group pelvic yoga program for women with chronic pelvic pain syndrome. The 5-year project aims to develop and rigorously evaluate a patient-centered, scalable, community-based self-management strategy...
This Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), will support research to investigate the role of urothelial cells in bladder sensory function and their contribution to visceral pain and sensory disorders. The $521,019 award to The Medical College of Wisconsin, Inc. aims to functionally and molecularly identify the population of sensory...
The National Institutes of Health National Institute of Neurological Disorders and Stroke awarded an $11.2 million project grant to the University of Pittsburgh to define the mechanisms of pain relief associated with dorsal root ganglion and spinal cord stimulation. This three-year grant will support research under the Drug Abuse and Addiction Research Programs (CFDA 93.279) to advance understanding of neuromodulatory devices for chronic pain treatment. The University will conduct preclinical...
This $14.2 million project grant from the National Institute of Neurological Disorders and Stroke, part of the Department of Health and Human Services, will fund research from September 2022 to August 2025 under the Drug Abuse and Addiction Research Programs (CFDA 93.279). The Massachusetts General Hospital will investigate the mechanisms by which spinal cord stimulation reduces pain, with the goal of improving device design and patient selection. Researchers will apply specialized nerve...
This federal Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $625,060 to The Washington University to elucidate the roles of distinct spinal cord cell types in mediating interstitial cystitis (IC)/bladder pain syndrome (BPS). The key objectives of this 5-year research project are to: 1) use chemogenetics and optogenetics approaches to...
This Project Grant award, valued at $730,883, was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847). The award will fund research to investigate the molecular and cellular mechanisms underlying visceral pain associated with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and Irritable Bowel Syndrome (IBS), as well as the cross-sensitization between these two...
SACRAL NEUROMODULATION FOR THE MANAGEMENT OF CHRONIC PELVIC PAIN - ABSTRACT PELVIC PAIN SYNDROMES ARE ONE OF THE MOST PREVALENT AND CHALLENGING CONDITIONS FOR CLINICIANS TODAY. THEY HAVE A HIGHER INCIDENCE IN WOMEN THAN MEN AND ARE ESTIMATED TO AFFECT 6.4 - 25.4% OF ADULT WOMEN WORLDWIDE. CHRONIC PELVIC PAIN (CPP) IS DEFINED AS NONMALIGNANT PERSISTENT PAIN PERCEIVED IN STRUCTURES OR ORGANS OF THE PELVIS FOR AT LEAST 6 MONTHS AND CAN HAVE A WIDE VARIETY OF ETIOLOGIES. CPP HAS A DEBILITATING EFFECT ON QUALITY OF LIFE, EQUIVALENT TO THOSE ON DIALYSIS, AND IS ASSOCIATED WITH PSYCHOLOGICAL COMORBIDITY INCLUDING DEPRESSION, ANXIETY, AND SLEEP DISORDERS. IDENTIFYING THE ORIGIN OF THE PELVIC PAIN IS TYPICALLY THE FIRST STEP WHEN CHOOSING A TREATMENT STRATEGY. HOWEVER, IDENTIFYING THE ETIOLOGY CAN BE CHALLENGING IN PART BECAUSE PAIN ASSOCIATED WITH CPP IS THOUGHT TO BECOME CENTRALIZED OVER TIME AND THE DYSFUNCTION OF ONE ORGAN SYSTEM OFTEN RESULTING IN PATHOLOGIES IN OTHER ORGANS. GIVEN THE COMPLEX CO-MORBID CONDITIONS THAT DEFINE THE PHENOTYPE OF MOST PATIENTS WITH CPP, ANY TREATMENT THAT MAY POTENTIALLY IMPROVE SEVERAL DOWNSTREAM PELVIC ORGANS AND/OR SYMPTOMS IS DESIRABLE. AS SUCH, WE PROPOSE TO USE SACRAL NEUROMODULATION (SNM) AS A TREATMENT FOR CPP. SNM IS A SAFE, EFFECTIVE, AND MINIMALLY INVASIVE PROCEDURE USED TO TREAT URINARY AND FECAL INCONTINENCE, FREQUENCY, URGENCY, AND URINARY RETENTION. NUMEROUS RETROSPECTIVE STUDIES HAVE DEMONSTRATED A REDUCTION IN PELVIC PAIN AS A SECONDARY OUTCOME MEASURE WITH SNM. HOWEVER, TO DATE, NO PROSPECTIVE PLACEBO-CONTROLLED TRIAL HAS BEEN PERFORMED TO ASSESS THE EFFECTIVENESS OF SNM FOR PELVIC PAIN SPECIFICALLY, IN PART BECAUSE SNM IS CURRENTLY NOT AN FDA APPROVED TREATMENT FOR CPP. THUS, WE HYPOTHESIZE THAT SACRAL NEUROMODULATION IS EFFECTIVE AT REDUCING PAIN IN PATIENTS SUFFERING FROM CHRONIC PELVIC PAIN SYNDROME. WE FURTHER HYPOTHESIZE THAT SINGLE STAGE SNM IMPLANTATION IS MORE COST-EFFECTIVE AND PROVIDES HIGHER BENEFIT TO PELVIC PAIN PATIENTS THAN THE STANDARD-OF-CARE 2-STAGE APPROACH. OUR HYPOTHESIS WILL BE TESTED THROUGH TWO SPECIFIC AIMS: 1. ASSESS EFFECTIVENESS OF SNM IN TREATING CHRONIC PELVIC PAIN SYNDROME IN WOMEN; 2. EVALUATE COST-EFFECTIVENESS OF SINGLE STAGE VERSUS STANDARD-OF-CARE 2-STAGE SNM. BEAUMONT UROLOGY IS INTERNATIONALLY RECOGNIZED FOR ITS EXPERTISE IN NEUROMODULATION AND A LARGE NUMBER OF WOMEN WITH CPP SEEK CARE AT OUR WOMEN'S UROLOGY CENTER ANNUALLY. THUS, OUR TEAM IS WELL-SUITED TO SUCCESSFULLY COMPLETE THESE AIMS. THE OUTCOMES OF THIS STUDY WILL HAVE A FAR-REACHING IMPACT AS IT HAS THE POTENTIAL TO SIGNIFICANTLY IMPROVE CARE FOR CPP AND SIMULTANEOUSLY ADDRESS MANY UNKNOWNS IN THE FIELD OF NEUROMODULATION, SUCH AS DETERMINE THE PLACEBO AND CARRY-OVER EFFECTS. AS SUCH, STUDY FALLS WITHIN THE MISSION OF THIS RFA TO FOSTER NEW AND IMPROVED TREATMENT AND PAIN MANAGEMENT STRATEGIES FOR PATIENTS AND TO ADDRESS SPECIFIC NIDDK DISORDERS OF KEY IMPORTANCE, NAMELY UROLOGIC CHRONIC PELVIC PAIN SYNDROME.