Chronic Pelvic Pain (CPP) is a debilitating condition that impacts 20 percent of women in the United States. Unfortunately, CPP is a challenge to diagnose and treat as there are multiple disease etiologies. Due to its complexity, it often requires a multidisciplinary approach involving gynecologists, urologists, vascular surgeons, and interventional radiologists. CPP is strongly associated with significant impairments in quality of life and has negative impacts on mental health. It is one of the most common conditions treated in womens health and represents a substantial economic burden on women and health care systems. In fact, an excess of $39 billion USD is spent in direct and indirect costs for CPP in the United States alone each year. Unfortunately, many patients with CPP end up in emergency rooms, or in primary care clinics where they are prescribed opioids for treatment. In 2019, 22.1% of U.S. adults with chronic pain used a prescription opioid. Up to 58% of patients with CPP resort to analgesics including opioids. Research shows that opioid treatment is ineffective for chronic pain syndromes. As opioids are not recommended for CPP, physicians need more options to successfully treat this debilitating condition. Fortunately, V-Flow Medical is providing CPP sufferers with an innovative solution to help diagnose and treat CPP. Up to 40% of CPP cases are caused by pelvic venous insufficiency (PVI), also known as pelvic congestion syndrome (PCS). PVI occurs when there is retrograde blood flow in the ovarian or internal iliac veins. This causes blood stasis, leading to localized venous hypoxia, which in turn activates localized inflammation and activation of pain nociceptors. V-Flow Medical has designed the first diagnostic catheter and modular stent system that has been specifically designed to treat PVI that is caused by pelvic vein compressions (PVCs). In addition to providing excellent visualization of incompetent pelvic veins, a key advantage of the V-Flow V-Gauge catheter is its ability to determine a clinically significant pressure gradient across the compressed zone and pre-determine the clinical benefit of placing a stent through real-time pressure monitoring. This project utilizes an ovine model to evaluate the safety and efficacy of the catheter and stent-in-stent system to generate a successful device that will improve clinical outcomes for millions of women suffering from CPP each year.
Public Health Relevance Statement: PROJECT NARRATIVE Pelvic Venous Compression (PVC) is a common cause of Chronic Pelvic Pain (CPP) in women, yet many women struggle to find an accurate diagnosis for the cause of their pelvic pain. Consequently, many suffer from decreased quality of life and seek chronic pain medication to help manage their symptoms. Fortunately, V-Flow Medical has developed the first venous catheter and stent-in-stent system to directly diagnose and treat CPP caused by PVC to help improve the lives of millions of women suffering from pain.
Project Terms: 21+ years old; Adult Human; adulthood; Adult; Analgesic Agents; Analgesic Drugs; Analgesic Preparation; Anodynes; Antinociceptive Agents; Antinociceptive Drugs; pain killer; pain medication; pain reliever; painkiller; Analgesics; Anatomic Sites; Anatomic structures; Anatomy; Blood; Blood Reticuloendothelial System; Blood Vessels; vascular; Calibration; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Diagnosis; Disease; Disorder; Therapeutic Embolization; Embolization Therapy; Embolotherapy; embolization; Fluoroscopy; Healthcare Systems; Health Care Systems; Histology; Hysterectomy; Iliac Vein; Inflammation; Mental Health; Mental Hygiene; Psychological Health; Nociceptors; nociceptive neurons; pain-sensing neurons; pain-sensing sensory neurons; pain-sensing somatosensory neurons; Obstruction; Pain; Painful; Patients; Pelvic Pain; Pelvis; Pelvic; Pelvic Region; Phlebography; Venography; Physicians; pressure; Quality of life; QOL; Research; Resort; Risk; Safety; Stents; Swelling; Syndrome; Testing; Time; United States; Veins; Venous Insufficiency; Woman; Measures; Women's Health; Female Health; Catheters; chronic pain; improved; Procedures; Ovarian; Clinical; Phase; Medical; Ensure; Blood flow; Gynecologist; Hypoxic; Oxygen Deficiency; Hypoxia; Opiates; Opioid; Measurement; radiologist; Urologist; fluid; liquid; Liquid substance; Venous; Diagnostic; Nature; System; Overweight; Over weight; Closure by clamp; Clampings; Accident and Emergency department; Emergency Department; Emergency room; Surgeon; success; novel; Devices; Intervention; Intervention Strategies; interventional strategy; Causality; causation; disease causation; Etiology; Address; Symptoms; Direct Costs; Economic Burden; Applications Grants; Grant Proposals; Facilities and Administrative Costs; Indirect Costs; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; chronic pelvic pain; chronic pelvic pain syndrome; designing; design; clinical efficacy; Outcome; Trauma; innovate; innovative; innovation; Impairment; clinical significance; clinically significant; multidisciplinary approach; interdisciplinary approach; FDA approved; minimally invasive; effective treatment; effective therapy; bio-markers; biologic marker; biomarker; Biological Markers; safety testing; efficacy testing; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; prescription opioid; accurate diagnosis; histological samples; histology samples; histology specimens; histological specimens; reduce pain; pain reduction; relieve pain; pain relief; stent thrombus; Visualization; ovine animal model; ovine model; sheep model; parous; diagnostic tool; primary care clinic; Diameter
