RECRUITING

National Program to Overcome Pelvic Pain studY (POPPY)

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Conditions

Chronic Pelvic Pain Syndrome (CPPS)Chronic Pelvic Pain SyndromeChronic Pelvic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

National Program to Overcome Pelvic Pain studY (POPPY)

Quick Facts

Study Start:2025-04-01
Study Completion:2029-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06778070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women (individuals reporting female sex assigned at birth who self-identify as women or non-binary) aged 18 years or older
  2. * Report chronic or recurrent pain in the pelvis (between or below the anterior iliac crests) for at least 6 months
  3. * Report at least moderate pain intensity based on a screening pain log
  4. * Report prior clinical evaluation of their pelvic pain by a healthcare professional including at least a superficial pelvic exam
  5. * Willing to refrain from initiating new clinical treatments that may affect their pain during the study period
  1. * 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)
  2. * 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
  3. * 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)
  4. * Currently pregnant (by self-report or screening test), pregnant within the past 12 weeks, or planning pregnancy during the study period
  5. * 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)
  6. * 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
  7. * 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)
  8. * 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
  9. * 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
  10. * Participation in another interventional study that might interfere with or confound study procedures, or known conflict with multiple upcoming study intervention class dates
  11. * Inability to understand the informed consent form or fill out questionnaires or complete study interviews
  12. * 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)

Contacts and Locations

Study Contact

Alison Huang, MD, MAS, MPhil
CONTACT
415-514-8697
Alison.Huang@ucsf.edu
Carolyn Gibson, PhD
CONTACT
415-205-4108
carolyn.gibson@ucsf.edu

Principal Investigator

Alison Huang, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Carolyn Gibson, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94115
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Alison Huang, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Carolyn Gibson, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2029-03-15

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2029-03-15

Terms related to this study

Additional Relevant MeSH Terms

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