Program to Overcome Pelvic Pain Study

Not Recruiting

Trial ID: NCT04615247


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
Leslee L.Subak, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Urology


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

   - 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


other: Yoga Program

other: Physical Conditioning Program

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham