NCT05750212

Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions

Official Title:

Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions (The MSK-PELVIC Study)

Summary

The purpose of this study is to learn about nerve function and pelvic muscle function. To do this we will compare the pelvic nerve and muscle function of women with chronic pelvic pain to those who do not have chronic pelvic pain. Understanding the pain may lead to better treatments in the future.

Eligibility

Inclusion Criteria:

* Female sex
* Age 21 to 80 years
* Symptoms of CPP as defined by the American College of Obstetrics \& Gynecology (ACOG) for more than 6 months
* At least two of seven overlapping CPP diagnosis (i.e., IC/PBS, IBS, Endometriosis, Vulvodynia, PN, FM, PFMP)
* An average CPP pain score of at least three on a 10 point pain scale

Exclusion Criteria:

* Current or history of GI or GU pelvic cancer
* Current pelvic infection (e.g., a UTI or vaginal infection)
* Current or imminent planned pregnancy or recent delivery in the last 6 months
* Abdominal or pelvic surgery in the last 36 months.

Disease(s) and\or Condition(s)

Chronic Pelvic Pain Syndrome

Primary Purpose
Intervention/Treatment
    • Type: DIAGNOSTIC_TEST
    • Name: Tone
    • Description: Tone is a binary measurement of the pelvic floor muscle on physical examination
    • Arm Group Labels: Cases, Controls
    • Type: DIAGNOSTIC_TEST
    • Name: Tenderness
    • Description: Tenderness is a binary measurement of the pelvic floor muscle on physical examination
    • Arm Group Labels: Cases, Controls
    • Type: DIAGNOSTIC_TEST
    • Name: Contraction
    • Description: Contraction is a binary measurement of the pelvic floor muscle on physical examination
    • Arm Group Labels: Cases, Controls
    • Type: DIAGNOSTIC_TEST
    • Name: Relaxation
    • Description: Relaxation is a binary measurement of the pelvic floor muscle on physical examination
    • Arm Group Labels: Cases, Controls
    • Type: DIAGNOSTIC_TEST
    • Name: Electromyography
    • Description: Electromyography is a measurement of the pelvic floor muscle in microvolts
    • Arm Group Labels: Cases, Controls
    • Type: DIAGNOSTIC_TEST
    • Name: Transperineal
    • Description: Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound
    • Arm Group Labels: Cases, Controls
    • Type: DIAGNOSTIC_TEST
    • Name: Pressure
    • Description: Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer
    • Arm Group Labels: Cases, Controls
Sponsor
  • Loyola University