Remote pelvic floor yoga program for chronic pelvic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.