Clinical trial NCT06083597: Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain
Official title: Development of a Patient-reported Outcome (PRO) Measure for Women With Chronic Pelvic Pain (CPP)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Pelvic Pain Syndrome
Pelvic Congestive Syndrome
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Society of Interventional Radiology Foundation
name: Evidera
First posted: 2023-10-16
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with chronic pelvic pain (CPP) meeting the American College of Obstetricians and Gynecologists criteria.

Brief 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.

Detailed description: The purpose of this study is to develop a patient-reported outcome (PRO) instrument that can be utilized as an efficacy endpoint to assess medical and surgical treatments of chronic pelvic pain (CPP) in comparative outcomes research.

This instrument will be developed consistent with Food and Drug Administration (FDA) guidance to be appropriate as an efficacy measurement in a clinical trial. The development of such a PRO measure is iterative, and this research protocol includes the qualitative research to develop a draft measure and document content validity. Content validity is first assessed through concept elicitation interviews, followed by cognitive interviews.

Patients who are eligible and consent to participate will:

1. complete a series of standardized health questionnaires
2. participate in an interview with a scientist who is an expert at developing this kind of PRO instrument who will ask patients about the impacts of their COO on their overall health and well being.

The information collected from a series of these interviews will lead to the development of a draft questionnaire which will then be reviewed with additional women with similar causes of CPP as well as with women with other causes of CPP to determine its usability and accuracy at assessing the impacts of CPP on their health and well being.

A final version of the PROM instrument will then be shared with women with CPP before and after any treatment to determine its ability to identify changes in their health and wellbeing.

Eligibility criteria: I. First phase of study evaluation women with presumed venous origin chronic pelvic pain

Inclusion Criteria :

1. Non-menopausal women ≥18 years old.

   a. Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
2. CPP meeting the American College of Obstetricians and Gynecologists criteria.
3. 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.
4. Imaging demonstrating multiple tortuous pelvic varicose veins \> 5 mm in diameter in the ovarian, utero vaginal, and/or uterine arcuate venous plexus.

   a. Imaging must be documented from trans vaginal ultrasound, trans abdominal ultrasound, magnetic resonance imaging, computed tomography, catheter venogram, or trans fundal pelvic venogram. If laparoscopic images are available to confirm veins this size, this would be acceptable as well.
5. 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:

   a. Symptoms: i. CPP increased with standing, walking, or lifting ii. CPP increased at the end of the day iii. CPP improved by laying down iv. Sexually provoked prolonged post-coital ache b. Physical findings: i. Adnexal tenderness on gentle bimanual exam ii. Tenderness at the ovarian point trans-abdominally iii. Tenderness of the uterus
6. Participant can read, communicate clearly, and understand English or Spanish.
7. Participant is willing and able to participate in an interview and complete questionnaires.
8. Participant is willing and able to provide informed consent.

Exclusion Criteria:

1. 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.
2. Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
3. Obvious endometriosis based on physical exam or laparoscopy findings.
4. Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
5. 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

II. Second phase of study evaluation women with non-venous origin chronic pelvic pain

Inclusion Criteria :

1. Non-menopausal women ≥18 years old.

   a. Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
2. CPP meeting the American College of Obstetricians and Gynecologists criteria.
3. 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.
4. Imaging demonstrating multiple tortuous pelvic varicose veins \> 5 mm in diameter in the ovarian, utero vaginal, and/or uterine arcuate venous plexus.

   a. Imaging must be documented from trans vaginal ultrasound, trans abdominal ultrasound, magnetic resonance imaging, computed tomography, catheter venogram, or trans fundal pelvic venogram. If laparoscopic images are available to confirm veins this size, this would be acceptable as well.
5. 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:

   a. Symptoms: i. CPP increased with standing, walking, or lifting ii. CPP increased at the end of the day iii. CPP improved by laying down iv. Sexually provoked prolonged post-coital ache b. Physical findings: i. Adnexal tenderness on gentle bimanual exam ii. Tenderness at the ovarian point trans-abdominally iii. Tenderness of the uterus
6. Participant can read, communicate clearly, and understand English or Spanish.
7. Participant is willing and able to participate in an interview and complete questionnaires.
8. Participant is willing and able to provide informed consent.

Exclusion Criteria:

1. 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.
2. Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
3. Obvious endometriosis based on physical exam or laparoscopy findings.
4. Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
5. 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

Primary outcomes:
measure: Phase 1 qualitative concept elicitation interview
timeFrame: 1 month
Secondary outcomes:
measure: Phase 2 Qualitative cognitive interview
timeFrame: 1 month
measure: Phase 2 qualitative open-ended concept elicitation questions
timeFrame: 1 month
measure: Phase 2 qualitative cognitive interview
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Neil M Khilnani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evidera
name: Robin Pokrzywinski, PhD
role: STUDY_DIRECTOR
References: