# Novel Venous Device for the Treatment of Chronic Pelvic Pain

> **NIH NIH R43** · V-FLOW MEDICAL, INC. · 2023 · $299,518

## Abstract

PROJECT SUMMARY
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 women’s 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.

## Key facts

- **NIH application ID:** 10696574
- **Project number:** 1R43HD111082-01A1
- **Recipient organization:** V-FLOW MEDICAL, INC.
- **Principal Investigator:** Rodney Brenneman
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $299,518
- **Award type:** 1
- **Project period:** 2023-09-08 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10696574

## Citation

> US National Institutes of Health, RePORTER application 10696574, Novel Venous Device for the Treatment of Chronic Pelvic Pain (1R43HD111082-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10696574. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*