©2022 Stanford Medicine
Program to Overcome Pelvic Pain Study
Not Recruiting
Trial ID: NCT04615247
Purpose
To refine and evaluate the feasibility of procedures for a future full-scale efficacy trial
of a group-based therapeutic yoga intervention versus physical conditioning (stretching and
strengthening) intervention for women with chronic pelvic pain.
Official Title
A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women
Stanford Investigator(s)
Leslee L.Subak, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Urology
Eligibility
Inclusion Criteria:
- Women aged 18 years or older who report chronic or recurrent pelvic pain for at least
6 months
- Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale) on a
screening 7-day pain log
- Report prior clinical evaluation of 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 (note that women 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 month, or prior yoga therapy specifically directed a pelvic pain
- Currently pregnant (by self-report or screening test), pregnant within the past 6
months, or planning pregnancy
- Diagnosed with an alternate, reversible cause of pain that is unlikely to respond to
yoga and requires another treatment modality (e.g., current pelvic infection or a
gynecologic dermatosis)
- Initiation, dose escalation, or weaning of pharmacologic agents that may affect pelvic
pain severity in the past 1 month (e.g., pain medications, antidepressants,
anticonvulsants)-note that women on stable doses will be eligible
- Surgery to the genital or pelvic structures within 3 months, or prior cancer or
irradiation to these structures
- Use of formal psychological therapies specifically for pelvic pain (e.g., systematic
desensitization, sex therapy, cognitive therapy, relaxation therapy) within 1 month of
screening
- 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
- 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
- Known conflict with multiple available intervention class dates
- Inability to sign an informed consent or fill out questionnaires or complete study
interviews in English, or lacking technical requirements to complete intervention
classes or study visits by video
Intervention(s):
other: Yoga Program
other: Physical Conditioning Program
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kathryn Batham
650-724-7826