Remote pelvic floor yoga program for chronic pelvic pain
National Program to Overcome Pelvic Pain studY (POPPY)
NA · University of California, San Francisco · NCT06778070
This study tests whether a remote yoga program can help women with chronic pelvic pain feel better compared to a regular physical conditioning program.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06778070 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness of a fully remote, videoconference-based pelvic floor yoga program against a physical conditioning program for women suffering from chronic pelvic pain syndrome. Participants will be randomly assigned to one of the two interventions and will engage in the program over a specified period. The study aims to evaluate pain relief and overall improvement in quality of life for those with chronic pelvic pain. The trial is investigator-blinded to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have experienced chronic pelvic pain for at least six months and report moderate pain intensity.
Not a fit: Patients whose pelvic pain is exclusively linked to menstrual cycles or sexual intercourse may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide a non-invasive, accessible treatment option for women suffering from chronic pelvic pain.
How similar studies have performed: Other studies have shown promise in using yoga and physical conditioning for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Alison Huang, MD — University of California, San Francisco
- Study coordinator: Alison Huang, MD, MAS, MPhil
- Email: Alison.Huang@ucsf.edu
- Phone: 415-514-8697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pelvic Pain Syndrome, Chronic Pelvic Pain