NCT06083597

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Pelvic Pain Syndrome
• Pelvic Congestive Syndrome

Interventions

Type	Name	Description
OTHER	Qualitative interview	Qualitative interviews will be performed on women with chronic pelvic pain of venous origin.

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-16
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States