National Program to Overcome Pelvic Pain studY (POPPY)

Last updated: April 15, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pelvic Pain

Dysmenorrhea (Painful Periods)

Interstitial Cystitis

Treatment

Pelvic floor yoga

Physical conditioning

Clinical Study ID

NCT06778070
24-41220
R01AT012461
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women (individuals reporting female sex assigned at birth who self-identify as womenor non-binary) aged 18 years or older

  • Report chronic or recurrent pain in the pelvis (between or below the anterior iliaccrests) 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 professionalincluding at least a superficial pelvic exam

  • Willing to refrain from initiating new clinical treatments that may affect theirpain during the study period

Exclusion

Exclusion Criteria:

  • Report pelvic pain occurring exclusively with menses or exclusively during sexualintercourse (although candidates with at least some pain between menses orintercourse 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 atpelvic pain

  • Lacking technical requirements to complete intervention classes by video, includingno 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 loandevices to participants from underrepresented backgrounds)

  • Currently pregnant (by self-report or screening test), pregnant within the past 12weeks, or planning pregnancy during the study period

  • Diagnosed with an alternate, reversible cause of pelvic pain that is unlikely torespond to yoga and requires another treatment modality (e.g., current pelvicinfection 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 studyperiod

  • Initiation, dose escalation, or weaning of pharmacologic agents that may affectpelvic pain severity in the past 4 weeks, such as analgesics, antidepressants, oranticonvulsants-(however, women on stable doses of these medications for at least 4weeks will still be eligible)

  • Use of formal psychological therapies specifically for pelvic pain (e.g., systematicdesensitization, 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 standingposition without assistance

  • Participation in another interventional study that might interfere with or confoundstudy procedures, or known conflict with multiple upcoming study intervention classdates

  • Inability to understand the informed consent form or fill out questionnaires orcomplete study interviews

  • Any other serious physical or mental issue that, in the opinion of theinvestigators, would interfere with study participation (e.g., advanced dementia,uncontrolled substance use or serious mental illness, life expectancy <6 months)

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Pelvic floor yoga
Phase:
Study Start date:
April 17, 2025
Estimated Completion Date:
March 15, 2029

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94115
    United States

    Active - Recruiting

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