Pelvic Floor Physical Therapy-Biomarkers Project

Completed

• Conditions: Pelvic Pain
• Interventions: Other: Pelvic floor PT with biomarkers

• Registration Number: NCT01669694
• Lead Sponsor: Kenneth Peters, MD

Brief Summary

This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.

Detailed Description

Collection points will be baseline, and at the last PT visit.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.

Exclusion Criteria

• all others

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with Pelvic Pain	Pelvic floor PT with biomarkers	Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center

Primary Outcome Measures

Name	Time	Method
The change in biomarkers pre- and post-pelvic floor PT	pre- and post- pelvic floor PT	Interim Analysis to be done as PI determines.

Secondary Outcome Measures

Name	Time	Method
Evaluation of biomarkers in relation to clinical findings	pre- and post- pelvic floor PT	Clinical data and biomarkers will be analyzed.

Trial Locations

Locations (1)

Beaumont Women's Urology Center; 🇺🇸 Royal Oak, Michigan, United States