National Program to Overcome Pelvic Pain studY (POPPY)

NCT ID: NCT06778070

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2029-03-15

Brief 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.

Conditions

Chronic Pelvic Pain Syndrome (CPPS); Chronic Pelvic Pain Syndrome; Chronic Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pelvic floor yoga

Intervention Type: OTHER

Pelvic floor yoga

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.

Group Type: ACTIVE_COMPARATOR

Physical conditioning

Intervention Type: OTHER

Physical conditioning

Interventions

Pelvic floor yoga

Pelvic floor yoga

Intervention Type: OTHER

Physical conditioning

Physical conditioning

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Huang, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Carolyn Gibson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alison Huang, MD, MAS, MPhil

Role: CONTACT

Alison.Huang@ucsf.edu

415-514-8697

Carolyn Gibson, PhD

Role: CONTACT

carolyn.gibson@ucsf.edu

415-205-4108

Facility Contacts

Claudia Vila Manes

Role: primary

PelvicPainStudy@ucsf.edu

415-353-4122

Jenny Chen

Role: backup

PelvicPainStudy@ucsf.edu

415-353-4122

Other Identifiers

R01AT012461

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-41220

Identifier Type: -

Identifier Source: org_study_id