Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain

NCT06083597 | Enrolling By Invitation

• 1 other identifier: 23-02025699
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Congestive Syndrome; Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Phase 2 Qualitative cognitive interview

  1 month

• Phase 2 qualitative open-ended concept elicitation questions

  1 month

• Phase 2 qualitative cognitive interview

  1 month

Study Arms (2)

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

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

Interventions

Qualitative interview OTHER

Qualitative interviews will be performed on women with chronic pelvic pain of venous origin.

Chronic pelvic pain of non-venous origin; Chronic pelvic pain of venous origin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Menstruating women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Non-menopausal women ≥18 years old.
• a. Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
• 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.
• 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.
• 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
• 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.

You may not qualify if:

• 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
• II. Second phase of study evaluation women with non-venous origin chronic pelvic pain
• Non-menopausal women ≥18 years old.
• a. Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
• 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.
• 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.
• 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
• Participant can read, communicate clearly, and understand English or Spanish.
• Participant is willing and able to participate in an interview and complete questionnaires.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Society of Interventional Radiology Foundation: collaborator
• Evidera: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Study Officials

• Neil M Khilnani, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Robin Pokrzywinski, PhD

  Evidera

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: October 16, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anticipated January 2025
• 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

Locations

US (1)