Pelvic Floor Physical Therapy-Biomarkers Project

October 13, 2015 updated by: Kenneth Peters, MD

Women's Urology Center-Physical Therapy-Biomarkers Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Women's Urology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with Pelvic Pain
Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center
Other: Pelvic floor PT with biomarkers
Pelvic floor physical therapy and collection of urine for biomarker analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in biomarkers pre- and post-pelvic floor PT
Time Frame: pre- and post- pelvic floor PT
Interim Analysis to be done as PI determines.
pre- and post- pelvic floor PT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of biomarkers in relation to clinical findings
Time Frame: pre- and post- pelvic floor PT
Clinical data and biomarkers will be analyzed.
pre- and post- pelvic floor PT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Peters, MD

Investigators

  • Principal Investigator: Donna J Carrico, NP, MS, William Beaumont Hospitals
  • Study Chair: Kenneth Peters, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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