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

Conditions

• Chronic Pelvic Pain Syndrome
• Pelvic Congestive Syndrome

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Qualitative interview — OTHER
  Qualitative interviews will be performed on women with chronic pelvic pain of venous origin.

Study Details

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.

Key Dates

Start date

Jul 1, 2023

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

55 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Phase 1 qualitative concept elicitation interview [ Time Frame: 1 month ]

Locations (1)

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