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

ConditionChronic Pelvic Pain Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age21-80

SponsorLoyola University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial population

Participants are selected from a tertiary medical care center

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Tone
Diagnostic test
Tone is a binary measurement of the pelvic floor muscle on physical examination
Tenderness
Diagnostic test
Tenderness is a binary measurement of the pelvic floor muscle on physical examination
Contraction
Diagnostic test
Contraction is a binary measurement of the pelvic floor muscle on physical examination
Relaxation
Diagnostic test
Relaxation is a binary measurement of the pelvic floor muscle on physical examination
Electromyography
Diagnostic test
Electromyography is a measurement of the pelvic floor muscle in microvolts
Transperineal
Diagnostic test
Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound
Pressure
Diagnostic test
Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer

Treatment groups

208 Participants

are divided into 2 treatment groups

Group A: Cases7 interventions

Group B: Controls7 interventions

Trial outcomes

Primary outcomes

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).

Time frame

0 Days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loyola University

Lead sponsor

Source ClinicalTrials.gov

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