Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain (PROM for CPP)

Development of a Patient-reported Outcome (PRO) Measure for Women With Chronic Pelvic Pain (CPP)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Pelvic Pain Syndrome; Pelvic Congestive Syndrome
• Intervention / Treatment: Other: Qualitative interview

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.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women with chronic pelvic pain (CPP) meeting the American College of Obstetricians and Gynecologists criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic pelvic pain of venous origin; Women who are thought to have chronic pelvic pain of venous origin will be interviewed to determine the impacts of their pain on physical, social and emotional aspects of their health and well being.	Other: Qualitative interview; Qualitative interviews will be performed on women with chronic pelvic pain of venous origin.
Chronic pelvic pain of non-venous origin; Women who are thought to have chronic pelvic pain of a non-venous origin will be interviewed to determine the impacts of their pain on physical, social and emotional aspects of their health and well being. They will be asked of the concepts identified by the women with venous origin CPP apply to them and if the impacts of the pain are similar or differ.	Other: Qualitative interview; Qualitative interviews will be performed on women with chronic pelvic pain of venous origin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 qualitative concept elicitation interview	Phase 1 qualitative interview about VO-CPP (Chronic pelvic pain originating from venous contribution) signs, symptoms, and impacts, from which a novel VO-CPP questionnaire (PeVD HRQoL) will be drafted, and ultimately assessed for content validity in the Phase 2 interviews. This Phase 1 interview will be conducted with subjects with VO-CPP.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2 Qualitative cognitive interview	Phase 2 qualitative interview will include questions about item clarity, how the participants interpret the items, ease of completing the PeVD HRQoL questions, questionnaire comprehensiveness, and the appropriateness of the questionnaire format and response scales. This Phase 2 interview will be conducted with subjects with VO-CPP.	1 month
Phase 2 qualitative open-ended concept elicitation questions	Phase 2 qualitative open-ended concept elicitation questions. This Phase 2 interview will be conducted with subjects with chronic pelvic pain originating from non-venous causes (NVO-CCP).	1 month
Phase 2 qualitative cognitive interview	Phase 2 qualitative interview about the content validity of the novel questionnaire, PeVD HRQoL, with subjects with chronic pelvic pain originating from non-venous causes (NVO-CCP).	1 month

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Society of Interventional Radiology Foundation; Evidera
• Investigators: Principal Investigator: Neil M Khilnani, MD, Weill Medical College of Cornell University; Study Director: Robin Pokrzywinski, PhD, Evidera

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease; Syndrome; Pelvic Pain
• Other Study ID Numbers: 23-02025699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, informed consent forms, de-identified data, analytic process and the clinical study report will be available for other researchers. The final patient reported outcome instrument will be made available for use by any investigator for clinical research by the study funder SIR Foundation
• IPD Sharing Time Frame: Anticipated January 2025
• IPD Sharing Access Criteria: The study protocol, consents and data supporting the PROM instrument will be made available for research purposes to investigators by the study PI. The final patient reported outcome instrument will be made available for use by any investigator for clinical research by license by the study funder SIR Foundation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No