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

NCT05750212 | Recruiting

• 1 other identifier: 213778
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Difference in two receiver operating characteristic curves

  The delta value between two diagnostic accuracy statistics (c-statistics) will be reported with its 95% confidence interval and significance value (p-value).

  0 Days

Study Arms (2)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

Diagnostic Test: Tone; Diagnostic Test: Tenderness; Diagnostic Test: Contraction; Diagnostic Test: Relaxation; Diagnostic Test: Electromyography; Diagnostic Test: Transperineal; Diagnostic Test: Pressure

Controls

Controls are adult female patients sampled from an outpatient primary care center

Diagnostic Test: Tone; Diagnostic Test: Tenderness; Diagnostic Test: Contraction; Diagnostic Test: Relaxation; Diagnostic Test: Electromyography; Diagnostic Test: Transperineal; Diagnostic Test: Pressure

Interventions

Tone DIAGNOSTIC_TEST

Tone is a binary measurement of the pelvic floor muscle on physical examination

Cases; Controls

Tenderness DIAGNOSTIC_TEST

Tenderness is a binary measurement of the pelvic floor muscle on physical examination

Cases; Controls

Contraction DIAGNOSTIC_TEST

Contraction is a binary measurement of the pelvic floor muscle on physical examination

Cases; Controls

Relaxation DIAGNOSTIC_TEST

Relaxation is a binary measurement of the pelvic floor muscle on physical examination

Cases; Controls

Electromyography DIAGNOSTIC_TEST

Electromyography is a measurement of the pelvic floor muscle in microvolts

Cases; Controls

Transperineal DIAGNOSTIC_TEST

Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound

Cases; Controls

Pressure DIAGNOSTIC_TEST

Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer

Cases; Controls

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are selected from a tertiary medical care center

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

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MeSH Terms

Interventions

Electromyography; Pressure

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Mechanical Phenomena; Physical Phenomena

Study Officials

• Colleen Fitzgerald, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary J Tulke, RN

CONTACT

7082162067; mtulke@luc.edu

Colleen Fitzgerald, MD

CONTACT

7082163387; cfitzgerald@lumc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: March 1, 2023
• Study Start: January 24, 2023
• Primary Completion: September 24, 2025
• Study Completion: October 24, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)