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 range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1 qualitative concept elicitation interview
Timeframe: 1 month
Trial details
NCT IDNCT06083597
SponsorWeill Medical College of Cornell University
. 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.
. 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.