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New treatment option for Chronic Pelvic Pain Syndrome (CPPS)
Official title National Program to Overcome Pelvic Pain studY (POPPY)
ClinicalTrials.gov ID: NCT06778070
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- Report pelvic pain occurring exclusively with menses or exclusively during sexual intercourse (although candidates with at least some pain between...
- Participation in organized yoga classes or muscle strengthening programs (e.g., Pilates) in the past 4 weeks, or any prior yoga therapy specifically...
- Lacking technical requirements to complete intervention classes by video, including no access to broadband internet or a Zoom-compatible device...
- 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...
- Surgery or irradiation to the genital or pelvic structures within the past 12 weeks, or anticipating upcoming surgery or irradiation to these...
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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]...
- 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...
- 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...
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.