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NCT01669694 Clinical Trial

Pelvic Floor Physical Therapy-Biomarkers Project

Pelvic Pain Clinical Trial

Official title:
Women's Urology Center-Physical Therapy-Biomarkers Project

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01669694
Other study ID # 2011-317
Secondary ID
Status Completed
Phase N/A
First received July 19, 2012
Last updated October 13, 2015
Start date October 2011
Est. completion date October 2013

Study information
Verified date October 2015
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Pelvic floor PT with biomarkers
Pelvic floor physical therapy and collection of urine for biomarker analysis.

Locations
Country Name City State
United States Beaumont Women's Urology Center Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
Kenneth Peters, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change in biomarkers pre- and post-pelvic floor PT Interim Analysis to be done as PI determines. pre- and post- pelvic floor PT No
Secondary Evaluation of biomarkers in relation to clinical findings Clinical data and biomarkers will be analyzed. pre- and post- pelvic floor PT No
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