Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain (NCT06083597) | Clinical Trial Compass
By InvitationNot Applicable
Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain
United States55 participantsStarted 2023-07-01
Plain-language summary
The purpose of this study is to develop a patient questionnaire that can be utilized to assess the benefit of treatments of chronic pelvic pain in research studies.
The information collected from a series of patient interviews will lead to the development of a questionnaire that accounts for the full impact of chronic pelvic pain from an affected woman's perspective.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Non-menopausal women ≥18 years old.
✓. CPP meeting the American College of Obstetricians and Gynecologists criteria.
✓. Patient pain is primarily of pelvic and/or pelvic floor origin. Patient may experience other pain symptoms, including bowel, bladder, musculoskeletal, skin allodynia and hyperalgesia, or lower extremity venous or vulvar pain.
✓. Imaging demonstrating multiple tortuous pelvic varicose veins \> 5 mm in diameter in the ovarian, utero vaginal, and/or uterine arcuate venous plexus.
✓. Venous contribution to CPP, as determined by clinical impression from a CPP specialist. Clinical impression will be based on the presence of the following symptoms and physical findings:
✓. Participant can read, communicate clearly, and understand English or Spanish.
✓. Participant is willing and able to participate in an interview and complete questionnaires.
✓. Participant is willing and able to provide informed consent.
Exclusion criteria
✕. Pain symptoms should primarily be of pelvic and/or pelvic floor origin (inclusion criteria #3 above). Pain should not be exclusively low back, hips, symphysis, allodynia or hyperalgesia of the skin, or from varicose veins of the vulvar and/or lower extremities.
✕. Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
What they're measuring
1
Phase 1 qualitative concept elicitation interview
Timeframe: 1 month
Trial details
NCT IDNCT06083597
SponsorWeill Medical College of Cornell University
✕. Obvious endometriosis based on physical exam or laparoscopy findings.
✕. Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
✕. Participant has any clinically relevant medical condition (e.g., severe co morbid condition, severe mental illness, severe visual or auditory impairment, or cognitive impairment) that, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures
✕. Non-menopausal women ≥18 years old.
✕. CPP meeting the American College of Obstetricians and Gynecologists criteria.
✕. Patient pain is primarily of pelvic and/or pelvic floor origin. Patient may experience other pain symptoms, including bowel, bladder, musculoskeletal, skin allodynia and hyperalgesia, or lower extremity venous or vulvar pain.