National Program to Overcome Pelvic Pain studY (POPPY)

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 10, 2025

Keywords

ClinConnect Summary

The POPPY study is a clinical trial designed to help women with chronic pelvic pain syndrome (CPPS), which is ongoing pain in the pelvic area that lasts for at least six months. This trial will compare two different programs: one is a pelvic floor yoga program that participants can attend via video conference, and the other is a physical conditioning program. Both programs are aimed at understanding which approach is more effective in relieving pelvic pain.

Women aged 18 and older who have been experiencing moderate to severe pelvic pain may be eligible to join this study. Participants should have already seen a healthcare professional about their pain and must be willing to avoid starting any new treatments during the study. Those who have recently participated in organized yoga or muscle strengthening classes, or those with certain medical conditions, may not qualify. If you join the trial, you can expect to take part in regular online classes, receive support from the study team, and contribute to important research that could help others with similar pain issues in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women (individuals reporting female sex assigned at birth who self-identify as women or non-binary) aged 18 years or older
• • Report chronic or recurrent pain in the pelvis (between or below the anterior iliac crests) for at least 6 months
• • Report at least moderate pain intensity based on a screening pain log
• • Report prior clinical evaluation of their pelvic pain by a healthcare professional including at least a superficial pelvic exam
• • Willing to refrain from initiating new clinical treatments that may affect their pain during the study period
• Exclusion Criteria:
• • Report pelvic pain occurring exclusively with menses or exclusively during sexual intercourse (although candidates with at least some pain between menses or intercourse are still eligible)
• • Participation in organized yoga classes or muscle strengthening programs (e.g., Pilates) in the past 4 weeks, or any prior yoga therapy specifically directed at pelvic pain
• • Lacking technical requirements to complete intervention classes by video, including no access to broadband internet or a Zoom-compatible device larger than a smartphone \[display screen at least 7 inches in diagonal\] (although the study team may loan devices to participants from underrepresented backgrounds)
• • Currently pregnant (by self-report or screening test), pregnant within the past 12 weeks, or planning pregnancy during the study period
• • Diagnosed with an alternate, reversible cause of pelvic pain that is unlikely to respond to yoga and requires another treatment modality (e.g., current pelvic infection or a gynecologic dermatosis)
• • Surgery or irradiation to the genital or pelvic structures within the past 12 weeks, or anticipating upcoming surgery or irradiation to these structures during the study period
• • Initiation, dose escalation, or weaning of pharmacologic agents that may affect pelvic pain severity in the past 4 weeks, such as analgesics, antidepressants, or anticonvulsants-(however, women on stable doses of these medications for at least 4 weeks will still be eligible)
• • Use of formal psychological therapies specifically for pelvic pain (e.g., systematic desensitization, cognitive therapy, relaxation therapy) within 4 weeks of screening, or plans to engage in these therapies during the study period
• • Unable to walk up a flight of stairs or at least 2 blocks on level ground (i.e., functional capacity \< 4 METs), or unable to get up from a supine to a standing position without assistance
• • Participation in another interventional study that might interfere with or confound study procedures, or known conflict with multiple upcoming study intervention class dates
• • Inability to understand the informed consent form or fill out questionnaires or complete study interviews
• • Any other serious physical or mental issue that, in the opinion of the investigators, would interfere with study participation (e.g., advanced dementia, uncontrolled substance use or serious mental illness, life expectancy \<6 months)