RecruitingNot ApplicableNCT06778070

National Program to Overcome Pelvic Pain studY (POPPY)

Sponsor

University of California, San Francisco

Enrollment

220 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pelvic Pain Syndrome Chronic Pelvic Pain Syndrome (CPPS)

Summary

A randomized, parallel-group, investigator-blinded, comparative effectiveness trial of a fully remote, videoconference-based pelvic floor yoga program versus a physical conditioning program for women with chronic pelvic pain syndrome.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria12

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)