Chronic Pelvic Pain Syndrome (CPPS)POPPYNCT06778070
National Program to Overcome Pelvic Pain studY (POPPY)
A study testing Pelvic floor yoga and Physical conditioning in people with Chronic Pelvic Pain Syndrome (CPPS) and Chronic Pelvic Pain Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome (CPPS), Chronic Pelvic Pain Syndrome, Chronic Pelvic Pain
- What is being tested?
- Pelvic floor yoga and Physical conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 15 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Claudia Vila Manes, 415-353-4122, PelvicPainStudy@ucsf.edu
Jenny Chen, 415-353-4122, PelvicPainStudy@ucsf.edu
About this study
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.
- Being tested
- Pelvic floor yoga, Physical conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor yogaOther
Pelvic floor yoga
Physical conditioningOther
Physical conditioning
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor yoga program | Experimental | Instruction in the therapeutic yoga intervention will be delivered through 75-minute group classes occurring twice weekly for a 2-month (8-week) intervention instruction period, involving a trained instructor and an expected 6-10 students (a.k.a. participants) using a secure Zoom videoconference platform.
Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. Receives: Other: Pelvic floor yoga |
| Physical conditioning program (Skeletal muscle stretching and strengthening program) | Active comparator | The physical conditioning program (skeletal muscle stretching and strengthening program) intervention will begin with a group orientation led by a physical trainer, who will provide an overview of the program. This will be followed by 75-minute twice-weekly group classes, each with an expected class size of 6-10 participants, led by the same physical trainer who has received study-specific training from the study's expert physical therapist consultant, and using a secure Zoom videoconference platform.
Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. Receives: Other: Physical conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain intensity "on average" using standard 0-10 numerical rating scale, measured using logs in which participants self-report pain intensity over the past week, and assessed over 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Pelvic pain intensity "at its worst" using standard 0-10 numerical rating scale, measured using logs in which participants to self-report pain intensity over the past week, and assessed over 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Secondary outcomes (8)
Percent of participants achieving reductions in pelvic pain intensity "on average" of at least 30% from baseline (using a standard 0-10 numerical rating scale) after 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Percent of participants achieving reductions in pelvic pain intensity "at its worst" of at least 30% from baseline (using a standard 0-10 numerical rating scale) after 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Psychological impact of chronic pelvic pain, measured by the psychological domain score of the Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) over 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Sexual impact of chronic pelvic pain, measured by the sexual domain score of the Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) over 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
General interference of pain with daily functioning in women with CPPS, as measured by scores on the PROMIS Pain Interference 4a measure from baseline to 4 months of intervention
4 months of intervention (2 months of instruction as well as 2 months of maintenance.
Measured: After 4 months of intervention instruction and maintenance period.
Perceived stress as measured by scores on the 4-item Perceived Stress Scale over the 4-month intervention period
4-month intervention period (2 months of intervention instruction and 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Sleep quality as measured by scores on the PROMIS Sleep Disturbance Short Form over the 4-month intervention period
4-month intervention period (2 months of intervention instruction and 2 months of maintenance).
Measured: After 4 months of intervention instruction and maintenance period.
Pelvic problems-related sexual function as measured by scores on the Pelvic Problems Interference subscale of the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) over the 4-month intervention period
4-month intervention period (2 months of intervention instruction and 2 months of maintenance)
Measured: After 4 months of intervention instruction and maintenance period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start12 May 2025
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain Syndrome (CPPS)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Stanford University, Office of Research on Women's Health (ORWH)
- Responsible party
- Sponsor
- Investigators
- Alison Huang, MD, Principal investigator, University of California, San FranciscoCarolyn Gibson, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778070
- Sponsor's protocol ID
- 24-41220
- Other IDs
- R01AT012461
- Acronym
- POPPY
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Program to Overcome Pelvic Pain studY (POPPY)
- ClinicalTrials.gov ID
- NCT06778070
- Acronym / sponsor ID
- POPPY / 24-41220
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Stanford University, Office of Research on Women's Health (ORWH)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor yoga program | Experimental | Other: Pelvic floor yogaInstruction in the therapeutic yoga intervention will be delivered through 75-minute group classes occurring twice weekly for a 2-month (8-week) intervention instruction period, involving a trained instructor and an expected 6-10 students (a.k.a. participants) using a secure Zoom videoconference platform. Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. |
| Physical conditioning program (Skeletal muscle stretching and strengthening program) | Active comparator | Other: Physical conditioningThe physical conditioning program (skeletal muscle stretching and strengthening program) intervention will begin with a group orientation led by a physical trainer, who will provide an overview of the program. This will be followed by 75-minute twice-weekly group classes, each with an expected class size of 6-10 participants, led by the same physical trainer who has received study-specific training from the study's expert physical therapist consultant, and using a secure Zoom videoconference platform. Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor yogaPelvic floor yoga | Other | Pelvic floor yoga program |
| Physical conditioningPhysical conditioning | Other | Physical conditioning program (Skeletal muscle stretching and strengthening program) |
Primary outcome
Pelvic pain intensity "on average" using standard 0-10 numerical rating scale, measured using logs in which participants self-report pain intensity over the past week, and assessed over 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
Pelvic pain intensity "at its worst" using standard 0-10 numerical rating scale, measured using logs in which participants to self-report pain intensity over the past week, and assessed over 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
4 months of intervention (2 months of instruction as well as 2 months of maintenance)
8 secondary outcomes
Percent of participants achieving reductions in pelvic pain intensity "on average" of at least 30% from baseline (using a standard 0-10 numerical rating scale) after 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
Percent of participants achieving reductions in pelvic pain intensity "at its worst" of at least 30% from baseline (using a standard 0-10 numerical rating scale) after 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
Psychological impact of chronic pelvic pain, measured by the psychological domain score of the Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) over 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
Sexual impact of chronic pelvic pain, measured by the sexual domain score of the Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) over 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
General interference of pain with daily functioning in women with CPPS, as measured by scores on the PROMIS Pain Interference 4a measure from baseline to 4 months of intervention
Time frame: After 4 months of intervention instruction and maintenance period.
Perceived stress as measured by scores on the 4-item Perceived Stress Scale over the 4-month intervention period
Time frame: After 4 months of intervention instruction and maintenance period.
Sleep quality as measured by scores on the PROMIS Sleep Disturbance Short Form over the 4-month intervention period
Time frame: After 4 months of intervention instruction and maintenance period.
Pelvic problems-related sexual function as measured by scores on the Pelvic Problems Interference subscale of the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) over the 4-month intervention period
Time frame: After 4 months of intervention instruction and maintenance period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison Huang, MD principal investigator
University of California, San Francisco
Carolyn Gibson, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor yoga and Physical conditioning in people with Chronic Pelvic Pain Syndrome (CPPS) and Chronic Pelvic Pain Syndrome, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Huang, MD, MAS, MPhil (415-514-8697, Alison.Huang@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain intensity "on average" using standard 0-10 numerical rating scale, measured using logs in which participants self-report pain intensity over the past week, and assessed over 4 months of intervention (time frame: After 4 months of intervention instruction and maintenance period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.