CClinicalTrials.gg
RecruitingNCT06778070POPPYUpdated Mar 6, 2026

National Program to Overcome Pelvic Pain studY (POPPY)

An interventional study of Pelvic floor yoga and Physical conditioning in Chronic Pelvic Pain Syndrome (CPPS), Chronic Pelvic Pain Syndrome and Chronic Pelvic Pain, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

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.

02

Conditions studied

  • Chronic Pelvic Pain Syndrome (CPPS)
  • Chronic Pelvic Pain Syndrome
  • Chronic Pelvic Pain
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Pelvic floor yoga program

    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.

    Other: Pelvic floor yoga

  • Active comparator
    Physical conditioning program (Skeletal muscle stretching and strengthening program)

    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.

    Other: Physical conditioning

Interventions

  • OtherPelvic floor yoga

    Pelvic floor yoga

  • OtherPhysical conditioning

    Physical conditioning

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

  2. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

Secondary outcomes

  1. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

  2. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

  3. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

  4. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

  5. 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.

    Time frame: After 4 months of intervention instruction and maintenance period.

  6. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

  7. 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).

    Time frame: After 4 months of intervention instruction and maintenance period.

  8. 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)

    Time frame: After 4 months of intervention instruction and maintenance period.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06778070
Lead sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Stanford University, Office of Research on Women's Health (ORWH)
Responsible party
Sponsor
First posted
Jan 16, 2025
Start date
May 12, 2025
Primary completion
Jan 15, 2029 (estimated)
Completion
Mar 15, 2029 (estimated)
Last update
Mar 6, 2026

Study contacts

Alison Huang, MD, MAS, MPhil
Contact
Alison.Huang@ucsf.edu
415-514-8697
Carolyn Gibson, PhD
Contact
carolyn.gibson@ucsf.edu
415-205-4108
Alison Huang, MD
principal investigator · University of California, San Francisco
Carolyn Gibson, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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