Online Programs for Chronic Pelvic Pain
(CII-CPP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two online programs, Bend and My Pelvic Plan, designed to assist women with chronic pelvic pain (CPP). Researchers aim to determine how these programs impact sexual function, physical function, pain levels, and overall quality of life. One program uses a new web-based cognitive-behavioral approach, while the other is a physical activity app. Women who have experienced moderate to severe pelvic pain for at least six months and suffer from sexual dysfunction due to this pain may be suitable candidates. Participants must have internet access and a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the management of chronic pelvic pain.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments, so it's best to ask the study team for guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both treatment options in this study are safe and well-tolerated in other settings.
For Bend, a physical activity app, studies indicate it helps users with gentle stretching and yoga poses. These exercises are generally safe and can improve flexibility and relaxation, potentially aiding chronic pain.
My Pelvic Plan, a digital pelvic health program, has also undergone study. It is considered a medical device under FDA guidelines, meeting specific safety standards. Previous studies have shown improvements in pelvic pain, anxiety, and depression without major safety concerns.
Overall, both options have been used safely in other studies. However, as with any treatment, results can vary for each person. Always discuss any concerns with the trial team or your doctor.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for chronic pelvic pain because they offer innovative, non-drug approaches that can be accessed from anywhere. "My Pelvic Plan" is a novel web-based cognitive behavioral program, which helps patients manage pain through mental strategies and behavior modification, something that traditional medications don't address. Meanwhile, "Bend" is a commercially available remote application, providing a unique, convenient way for patients to engage with pain management techniques at their own pace. These digital options could revolutionize how we approach chronic pelvic pain by empowering patients with tools they can use in their daily lives without the side effects associated with medications like NSAIDs or opioids.
What evidence suggests that this trial's treatments could be effective for chronic pelvic pain?
Research has shown that both Bend and My Pelvic Plan may help with chronic pelvic pain (CPP). In this trial, participants will be randomized to receive one of these two non-pharmacologic interventions. Studies have demonstrated that Bend, a digital app for women's pelvic health, reduces pelvic pain, anxiety, and depression after 4 and 12 weeks of use. My Pelvic Plan, an online program, aids individuals in managing their own care and has been linked to improved quality of life and reduced impact from pelvic pain. These findings suggest that both programs might effectively manage CPP symptoms.25678
Who Is on the Research Team?
Sara Till, MD MPH
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for women with chronic pelvic pain, defined as moderate to severe non-cyclic pain lasting over six months. Participants must have internet access, a smartphone, and be proficient in English. They should be new patients at the University of Michigan's Chronic Pelvic Pain Clinic. Pregnant individuals or those with prior care from this clinic are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of two non-pharmacologic interventions: a novel web-based cognitive-behavioral program or a commercially available physical activity remote application
Follow-up
Participants are monitored for changes in sexual function, physical function, pain, and quality of life after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bend
- My Pelvic Plan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sara Till, MD, MPH
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator