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CompletedNCT02261740POPPYUpdated Oct 4, 2016

Program to Overcome Pelvic Pain With Yoga

An interventional study of Yoga Therapy in Pelvic Pain, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-04.

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

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
21 Years and older
Sex
Female
01

Study summary

The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report persistent or recurrent pelvic or genital pain for at least 6 months that interferes with sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel. Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that have been carefully selected for their potential to improve women's genito-pelvic pain and practice yoga at home one additional hour a week.

The investigators will evaluate changes in the severity and impact of women's pain using validated questionnaires and diaries.

02

Conditions studied

  • Pelvic Pain

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Keywords

  • Pelvic Pain
  • Genital Pain
03

In context

Pelvic Pain

375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.

This study's enrollment of 16 is below the median of 54 across 273 interventional studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 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.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Women aged 21 years or older who report difficulties with pelvic or genital pain for at least 6 months
  2. Report that their chronic pelvic or genital pain has had an adverse effect on their interest in or ability to enjoy sexual activity
  3. Report an eligible average daily pain intensity score after completion of a Daily Pain Log for one week prior to baseline
  4. Have an established primary care or gynecologic healthcare provider (to facilitate medical follow-up of any health issues detected incidentally in the study or adverse events that develop during the study)
  5. Report prior clinical evaluation of their pelvic or genital pain by a health care professional including at least a superficial pelvic exam
  6. Willing to refrain from initiating other new clinical treatments that may affect their pelvic or genital pain during the study period (6 weeks)

Exclusion criteria

Exclusion Criteria:

  1. Participation in organized yoga classes in the past 1 month, or any prior yoga therapy directed specifically at pelvic or genital pain (regardless of timing)
  2. Currently pregnant (by self-report or screening test), pregnant within the past 6 months, planning pregnancy during the study, or unwilling to use contraception (if not postmenopausal) during the study
  3. Diagnosed with an alternate cause of pain that is unlikely to respond to yoga and requires another treatment modality, such as pelvic infection or a gynecologic dermatosis
  4. Surgery to the vulva, vagina, cervix, or pelvic organs within 6 months of screening, or any prior history of cancer or irradiation to these structures
  5. Initiation of or dose escalation of pharmacologic agents that may affect pelvic or genital pain in the past 1 month (e.g., antidepressants, anticonvulsants, anxiolytics)-women on stable dose for >1 month are eligible
  6. Use of formal psychological therapies specifically for pelvic or genital pain (e.g., systematic desensitization, sex therapy, cognitive therapy, relaxation therapy) within 1 month of screening
  7. Use of formal behavioral therapies for pelvic or genital pain (e.g., pelvic floor rehabilitation or biofeedback performed by a certified healthcare practitioner) within 1 month of screening
  8. 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 in \<10 seconds
  9. Currently involved in a malpractice suit or other litigation specifically related to pelvic or genital pain
  10. Participation in another interventional study that might interfere with or confound study procedures, inability to sign an informed consent or fill out questionnaires, or conflict with available yoga class dates
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Yoga Therapy Group

    Participants will attend twice-weekly group yoga classes and be instructed to practice yoga at home one additional hour a week, using a written manual.

    Behavioral: Yoga Therapy

Interventions

  • BehavioralYoga Therapy

    A 90-minute orientation session led by the yoga class instructors, followed by 90-minute group yoga classes twice weekly for 6 weeks. Classes will be led by an experienced instructor. Women will also be taught to avoid any habits that may worsen their genito-pelvic pain (e.g., straining their pelvic floor muscles). Participants will also be asked to practice yoga at home an additional hour per week throughout the 6-week yoga therapy program. Participants will be given a detailed written manual to use for home practice.

06

What researchers measure

Primary outcomes

  1. Change from baseline in severity of pelvic pain after yoga therapy program.

    Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).

    Time frame: Baseline to 6-Weeks

Secondary outcomes

  1. Change in baseline sexual functioning after yoga therapy program.

    We will use standard questionnaires to assess changes in sexual function.

    Time frame: Baseline, 6-Weeks

  2. Change in baseline quality of life after yoga therapy program.

    We will use standard questionnaires to assess changes in overall quality of life.

    Time frame: Baseline, 6-Weeks

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Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02261740
Lead sponsor
University of California, San Francisco
Collaborators
Patty Brisben Foundation For Women's Sexual Health
Responsible party
Sponsor
First posted
Oct 10, 2014
Start date
Oct 2014
Primary completion
Mar 2016
Completion
Jun 2016
Last update
Oct 4, 2016

Study contacts

Alison Huang, MD, MAS
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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