Building a non-pharmacological treatment option for chronic pelvic pain

What's your design project and why is it important?

We worked with Tamatha B. Fenster, M.D., M.S., FACOG of Weill Cornell Medicine on a device to address chronic pelvic pain such as from menstrual periods (dysmenorrhea) or endometriosis. Dr. Fenster presented us with the need and a few design approaches toward a solution. Following a biodesign process in consultation with Dr. Fenster and Meinig School M.Eng. Director Dr. Newton de Faria, we designed and fabricated a unique shape “cup”, electrode placement and neural stimulation paradigm to meet the need. Designed to modulate nerve activity through controlled electrical impulses, the resulting TammyCup device thereby reduces need for and dependency on medications like opioids to treat this common type of pain in women. 

Pelvic pain afflicts as many as 32% of women aged 12 to 55 years old annually. About 190 million women are affected by endometriosis worldwide. Chronic pelvic pain and endometriosis significantly impact the quality of life for many individuals, and can lead sufferers to rely heavily on pharmacological treatments, including opioids.

Current treatment options are limited to pharmacological interventions such as non-steroidal anti-inflammatory drugs (NSAIDs), hormonal therapies (oral contraceptive pills, vaginal ring, and transdermal patch), and surgical procedures (laparoscopy, laparotomy, and hysterectomy), each with varying degrees of success and side effects, compounded by excessive opioid prescriptions.

Notably, women are four times more likely to develop an addiction to opioids compared to men, particularly when prescribed at young ages for severe pain. This dependency crisis underscores the urgency for alternative pain management solutions.

This project therefore served a dual purpose: to offer a non-pharmacological treatment that potentially reduces the need for opioids and to provide relief for conditions that have historically been challenging to manage through conventional medical practices. The initiative aligns with a critical health need, aiming to improve the lives of countless individuals suffering from these painful conditions by harnessing the therapeutic potential of neural stimulation directly within the pelvic region.

Any special aspects to your project?

Moderate to severe pain caused by menstrual periods (dysmenorrhea) is a condition that has affected many people across the globe for millennia, and yet options for treatment are still quite limited. Dr. Fenster shared with us that some young women come to her clinic in such severe pain that only opioids can lessen or improve their symptoms. This project is the culmination of our effort to support Dr. Fenster’s vision to bring her patients and millions of others around the world, some relief.

What have you learned over the course of this project?

We have learned that women’s health issues are massively understudied and underfunded. This project allowed us the opportunity to further the research and development of a medical device that has the potential to help many women affected by chronic pelvic pain and endometriosis.

Next steps or future direction for your project?

Moving forward, extensive testing is planned to ensure the device's comfort, safety, and effectiveness. Proposed verification tests include fit and comfort assessments, and formal Institutional Review Board (IRB)-approved studies on the electrical stimulation paradigm. Future directions include exploring other design options like tampon frames, integrating wireless communication, and developing a mobile interface. The team also plans to address regulatory challenges and refine business models to ensure the device's commercial viability.

The team