Understanding Pelvic Health in Women with Chronic Pain
Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions (The MSK-PELVIC Study)
This study looks at how pelvic muscles and nerves work in women with chronic pelvic pain compared to those without it to better understand the condition and improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 208 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | Female |
| Sponsor | Loyola University Academic / other |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT05750212 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the nerve and pelvic muscle function in women suffering from chronic pelvic pain (CPP) by comparing them to women without CPP. It seeks to explore the relationship between CPP and overlapping conditions such as interstitial cystitis, irritable bowel syndrome, and fibromyalgia. The study will utilize various assessments, including electromyography, to evaluate pelvic floor muscle responses and their potential links to musculoskeletal health. The findings may help clarify the underlying mechanisms of CPP and inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 to 80 with chronic pelvic pain lasting over six months and at least two overlapping diagnoses.
Not a fit: Patients with current or history of pelvic cancer, infections, recent pregnancies, or recent abdominal or pelvic surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for women suffering from chronic pelvic pain.
How similar studies have performed: While there is ongoing research in this area, the specific focus on the neuromuscular function of pelvic floor muscles in relation to chronic pelvic pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Maywood, Illinois
- Loyola Medical Center — Maywood, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Colleen Fitzgerald, MD — Loyola Medical Center
- Study coordinator: Mary J Tulke, RN
- Email: mtulke@luc.edu
- Phone: 7082162067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.